Independent Clinical Trial Oversight · Biotech, Pharma & Medical Device

Your clinical trial runs through a CRO and a chain of external vendors.
We manage and oversee every one of them, on your behalf.

Control, not just visibility.

Your trial is run by dozens of professionals across several organizations at once. We are the professional layer that oversees and manages all of them on your behalf: defining performance measures for the CRO and vendors and holding them to those measures, keeping a direct line of sight to the sites and the data, and managing the sponsor-side tasks together with your team. Every party delivers its best work, and control stays in your hands.

For pharma, biotech and medical device companies running clinical trials. ICH E6(R3) and ISO 14155 require sponsors to maintain oversight of every vendor and CRO they delegate to. Myrtle Clinical is the experienced, independent partner that sits on your side and does exactly that.

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Independent oversight layer Active
Myrtle Clinical
Oversight & management of every party, on your behalf
CROusually 1, sometimes more
Vendorsoften 10 or more
Sitesfrom 2 to dozens
In-house teamup to ~4, stretched
One independent layer oversees the CRO (Contract Research Organization), the vendors, the sites and your in-house team. Scope varies from trial to trial.
What you get out of it
Fewer fires to put outFewer surprise costsA trial that stays on trackResults you can trust
How Myrtle Clinical works

One goal, shared by everyone on your trial.

Your trial runs through the CRO, the vendor chain, the sites, and the activities your company handles internally. Each of them needs a layer that supports them and makes sure the work is the best and the right work for what you need. Myrtle Clinical is that layer, with one shared goal: helping every party be the best version of itself.

This is how a clinical trial is really run:

A strategy that makes the CRO and the sites prioritize your trial, and give you their best team, without constant turnover A precise protocol before submission, and precision fixes to an existing protocol when it's critical, because every amendment later costs months and budget A direct line to the site teams, so you know what is really happening on the ground, not only what is reported Structured measurement of the CRO's performance, and invoices approved only for what was truly delivered
And the regulation backs this too. Sponsor Oversight, the requirement to oversee the CRO and vendors, came into force with ICH E6(R3) and is checked in inspections:

“The sponsor should ensure oversight of any trial related duties and functions carried out on its behalf, including those subcontracted to another party by the sponsor's contracted CRO.”

ICH E6(R3), Good Clinical Practice, sponsor responsibilities

And not every trial faces an inspection? True. But every trial has to succeed: on schedule, within budget, and at the quality the data depends on. More on that in the FAQ.

ICH E6(R3) aligned Deep oncology focus, global Phase I–III experience Global clinical trials across US, EU & Israel Drug, biotech & medical device

Your clinical trial is in expert hands. Your control stays exactly where it belongs. With you.

Under ICH E6(R3), oversight means active, documented, risk based governance across the full trial lifecycle. Myrtle Clinical brings that capacity to your team, so your trial runs smoothly, stays aligned to the protocol, and keeps you in full control.

Why it matters

If you work with a CRO, you need this.

No matter how much of the work the CRO was given to run, the accountability for the work, and for the data being collected, stays with you alone. That is exactly why you need one more layer, independent and unbiased, that manages and oversees it all on your behalf: the CRO, the vendors, the data, and everything that stayed with you. That layer is Myrtle Clinical.

Your independent oversight arm
What we actually do

The layer above your CRO, the vendors, the sites and your internal work.

Across the CRO, the vendor chain, the sites and your internal work, one independent layer reads the work, checks it against the protocol and the budget, and keeps every party accountable to you.

CRO Vendors Sites You

CRO & vendor performance

The CRO presents its own KPIs, but it will never truly measure itself. We measure the CRO's work on your project from your side: reading the status reports between the lines, tracking delivery against KPIs and KRIs we define for you, making sure your trial always stays prioritized with them, and surfacing issues before they escalate.

Quality & inspection readiness

Risk based quality oversight and documented decisions that protect your data and keep the trial sound, and ready for an FDA, EMA or Ministry of Health inspection when one comes.

Vendor & budget oversight

Overseeing the full vendor chain and reviewing invoices against the work delivered, so nothing falls between the cracks.

A clinical team sharing results with a patient, where the science meets the person

A weekly report tells you what happened.
Real oversight changes what happens next.

Anyone can read a status update after the fact. The difference is having an experienced hand that reads between the lines, asks the right questions early, and steers the trial while there is still time to act. Our job in one sentence: making everyone you pay work better for you.

FAQ

Questions we are often asked

What is independent clinical trial oversight and management?

It is an independent layer of operational trial-running experience, on the sponsor's side. Most companies feel this is covered: there is a regulatory lead, a development manager, and a CRO that 'runs the trial'. But running a global trial operationally, with a CRO and a chain of vendors, is a profession of its own, and a CRO does not check its own work. A Myrtle team, people who have already run trials like yours, steps in on the sponsor's behalf, holds the full picture, manages and oversees the CRO and vendors, and makes sure the tasks that stay with the sponsor actually get done. The scope is matched to the trial: sometimes one person, sometimes several people from Myrtle on the same project, depending on the stage and the amount of data. Under ICH E6(R3) the accountability for the trial stays with the sponsor even when the work is outsourced to a CRO, and we give them the experience to actually carry it.

How is independent oversight different from a CRO?

The CRO's job is to run the trial on the ground: to manage the sites and oversee them. But the CRO works within its own scope and its own interests, and it cannot check its own work. We are on your side: we accompany, support, manage and oversee the CRO's activity, with a structured way to measure its performance and to make sure it meets the responsibility that sits with it. To do that for real, we do not rely on the CRO's reports alone; we keep an independent line of sight all the way down to the sites, so we always know what is actually happening on the ground, not only what is reported. On top of that, we take ownership of the tasks that stay on the sponsor's side and that the CRO never touches. A strong CRO is the start; getting its best performance, with nothing falling between the chairs, is what we secure.

Why an independent outside body, and not someone internal?

From the sponsor's side: a trial is a passing stage in the company's life, and building a full internal role for it takes time, costs money, and starts without the experience we have already built working across many CROs and many trials. An external, independent body is also not subject to internal politics, so it raises a problem in time, even when that is uncomfortable for everyone. From the CRO's side: independent oversight does not replace them, it helps them. We speak their language because we have worked on their side ourselves, so this is professional coordination between peers, not adversarial auditing. We give them one stable point of contact instead of a sponsor team that keeps changing, and fast answers and decisions from your side, which is exactly what keeps your trial prioritized with them.

Who is the oversight and management service for?

Biotech, pharma and medical device companies running a global trial through a CRO and vendors, especially when the team hired for the trial is small and new, or when a regulatory person has been asked to run the trial too without the experience or the availability for it. That is exactly where things start to fall between the chairs, and control, timelines and budget are put at risk.

We have a regulatory person running the trial. Why would we need you?

Because regulatory affairs and running a trial operationally are two different disciplines, and above all, two full-time jobs. Your regulatory lead already has a full plate, and managing a global trial with a CRO and vendors is a full-time job in itself. We do not replace them; we are the operational arm that frees them to do their own work at full strength, and keeps the trial from falling between the chairs.

How is AI used in clinical trial oversight and management?

Myrtle Clinical embeds AI into sponsor-side clinical operations in three ways: mapping where AI adds real value in the workflow, selecting and implementing the right tools for companies and CROs, and developing Oversight AI, an internal tool that surfaces risk signals in CRO and vendor data earlier and more consistently. Every decision stays human, documented and accountable, in line with ICH E6(R3).

How much does clinical trial oversight cost?

Pricing is built around the scope: the phase, number of sites and countries, trial duration and number of vendors. We are glad to give a tailored quote on a short call.

Do you work with drugs and with medical devices?

Yes. We work to the ICH GCP E6(R3) standard for drug and biotech trials, and to ISO 14155 for medical device investigations, aligned with what regulators worldwide expect.

Do you work with AI-based medical devices and digital health products?

Yes. Every AI-based medical device or digital health product eventually needs clinical validation: a real trial with sites, patients and data. Myrtle Clinical oversees and manages these trials on the developer's side: the CRO, the vendors, the sites, and the data quality the algorithm's evidence depends on. For AI-specific regulatory strategy and software risk files, we connect you to specialist partners, and stay the one layer that holds the whole trial together.

How do we start working with Myrtle Clinical?

Book a short intro call. Tell us about your trial, and we will show you exactly where independent oversight and management make the difference.

Who are the mentoring and courses for?

Clinical research professionals, from study coordinators and CRAs to project managers, regulatory, QA and data, who want to move up, step into a new role, or stay current with the standard and with AI in the field.

Where can I get clinical research career advice in Israel?

Myrtle Clinical offers 1:1 career mentoring for clinical research professionals in Israel and globally: advancing to the next role, returning to the field after a break, finding a new position, relocating abroad, or going independent. The mentors have held every role in the path, from study coordinator and CTA through CRA and CTM to founder, in global Phase I-III trials.

For biotech, pharma and medical device sponsors running a trial through a CRO

Run your clinical trial like an experienced sponsor. Even the first time.

Your clinical operations representative. Independent, and committed to one side only: yours.
CROThe sitesSpecialist vendorsInternal

Your trial runs through every one of them. No single one sees the whole picture, and the responsibility stays yours.

Even with an excellent CRO, the accountability for the trial stays with you. Myrtle Clinical is the experienced layer, on your side only, that represents you and makes sure you can carry that accountability, so the trial is managed and every party is aligned to the same goal.

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One interest only: your trialEvery indication, every phase, with a CRO or directly with sitesBuilt to ICH E6(R3) & ISO 14155Ready for FDA, EMA & Israeli Ministry of Health inspections
Our principle

On your behalf, never instead of you

Whoever runs your trial, the CRO, the vendors, even a clinical research unit inside a hospital that steps into the CRO role, we are the body that oversees and manages them on the sponsor's behalf, never instead of you. One independent layer beside you that keeps everything stable and working, holds every party true to the protocol, the timelines and the budget, your internal team included, and raises the flag in time when a problem appears. Because a CRO cannot oversee itself. And we have no other interest, not a CRO, not a vendor, no internal politics. We represent one side only: yours.

The question every sponsor should ask

You hired an excellent CRO. Who manages and oversees it on your behalf?

Just as important: does anyone on your side actually have the time for it? In most companies the same person wears several hats at once, leading development, handling regulatory affairs, and often expected to manage the CRO on top of that. Real, ongoing oversight demands dedicated time, and that is precisely what tends to be missing.

The right setup begins before the first site opens: submitting the most precise protocol possible, since every later amendment carries real risk. Throughout the trial, one layer is required whose role is to connect every party, verify execution, and drive a resolution whenever progress stalls. In the trials we accompany, the CRO performs at a high standard, not only because of its professionalism, but because it is managed correctly, and that is what allows everyone to work better.

And even when everything works, the workload keeps growing.

As the trial progresses, patients, data and queries accumulate, and the work grows steadily. Most sponsors do not plan for this in advance, so it lands on the internal team and wears it down. Our scope is built to grow together with the trial, and at critical times we also step in to temporarily reinforce your internal team and take load off.

WorkloadStart-upEnrollmentConductData & close-out
The shaded area is the gap that lands on your internal team.
The trial workloadA small internal team's capacityWith Myrtle: scope that grows with the trial
Mapped from the field

How do you become a prioritized sponsor?

Clinical trials run in a competitive world: your CRO has other clients alongside you, and the teams at the research sites run several active studies at once, under real, constant workload. Everyone prioritizes all the time; that is how the model works. The important question is how your trial becomes the one that gets their best team, kept stable over time, and their highest attention.

From our experience with many CROs across many studies, we map the challenges of the CRO as a company, and of the other vendors, and we know what makes a study prioritized inside them and what happens to a study that stays behind: the work moves slower and at a lower standard, and that reaches the sites too. We turn that knowledge into a strategy that makes everyone prioritize your trial, out of a genuine drive to give you their maximum.

The traditional model
Sponsor: youCROThe sites
Every update reaches you through one party.
With Myrtle Clinical
Sponsor: youMyrtleCROThe sites
A direct line to the CRO and to the sites.

And we stay in direct, continuous contact with the site teams as well: the study coordinators and investigators who actually run your trial. We hear from them how they experience the CRO, and they always have an address for questions and help. In the traditional model, everything you know about the sites arrives through the CRO alone; the direct channel we add is how you always know what is really happening on the ground.

This accompaniment goes down to the details that determine quality: guiding site teams on blood-sample processing so that every sample collected is a sample that can be analyzed, and close oversight of the central and local labs so that every sample that reaches them is handled correctly. These are exactly the points where field experience is worth real money.

How a clinical trial actually divides

Many hands run the clinical trial. One independent layer watches them all.

Independent Oversight Myrtle Clinical · one experienced layer over the entire trial THE CLINICAL TRIAL CRO primary vendor Internal your own work Sites the data Other vendors ten or more Central lab IRT / IxRS EDC Monitoring Drug supply Safety / PV Imaging Biostatistics Data Management Couriers Regulatory AI systems The work is delegated. The responsibility to oversee it is not. ICH E6(R3), sponsor responsibilities

A single clinical trial runs through the CRO, the work you run internally, the sites, and ten or more specialist vendors. Independent oversight is the one layer that holds the whole picture across all of them, and guards the protocol compliance and the safety and efficacy data the trial exists to generate, the data the product's approval, and future patients, depend on.

Oversight holds Protocol compliance Safety & efficacy data Vendor & CRO delivery Budget & timeline

Active management, not reports

We drive delivery and resolve issues with the CRO and vendors.

Plug in, don't build

A trial is a passing stage in the company's life. Instead of hiring a whole team for this temporary stage, you plug into an experienced body that is already working.

Expertise that stays

Years of running trials and overseeing CROs worldwide.

Making the people you pay work better for you

In every indication and every phase, with a CRO or directly with sites. And a partner to CROs that want to raise their own delivery.

Why it matters

Continuity that holds through every handover

A changing team

At every handover, knowledge walks out the door.

Problems surface late

They appear in a status report, not in time to act.

No single picture

CRO, vendors and sites: no one sees the whole.

Momentum slips

Every restart costs time, budget and risk.

Myrtle Clinical stays one experienced presence that holds the full picture and trains every new person who joins.
An experienced clinical research professional leading a trial oversight meeting with a project team loading=
How it works

How our oversight works

1

Map the risks

We identify what the trial truly depends on: the critical data and processes, scaled to the risk.

2

Set the oversight plan

Essential records, review frequency, thresholds and clear roles across the CRO and every vendor.

3

Monitor and review

Centralized, ongoing review of the CRO's work, the sites' work and every other vendor's work on the trial, and of the data, so issues surface early, not in a late status report.

4

Document and act

Every check and decision is documented, so the trial stays on track and inspection-ready.

What we do

One experienced team, across the whole trial

Whatever the trial needs, one experienced team covers the full scope: from set-up, through day-to-day management, to standing beside you in audits and inspections.

Set up
Run the study directlyChoose the right CRO & contracts
Run & oversee
Manage CRO & vendor deliveryVendor management
Protect
Quality & complianceInvoices & contracts
01Set up rightFrom CRO selection to the oversight plan

Running the study directly

When a full CRO is more than a study needs, often in early phases, we run it directly. Lean, close to the work, and built around the science, so the work moves fast with experienced people at the wheel.

Choosing the right CRO & contracts

We have worked with many CROs and know from the field how each one actually performs. So when a CRO is the right call, we match the one that truly fits your trial and recommend only the strong ones. We know the going market rates, run the negotiation, build the contracts, and make sure every area of responsibility is closed and clear, before the first patient enters the trial.

CRO & vendor selection

Choosing and qualifying the right CRO and vendors before you start, and defining the split of work and responsibility so nothing falls between the cracks.

Oversight plan & SOPs

Building the documented oversight plan and vendor oversight procedures that inspectors expect to see, ready and in place from day one.

02Manage & overseeThe day-to-day engine of the trial

Managing CRO & vendor delivery

Driving the daily work with the CRO and vendors: tracking delivery against KPIs and KRIs we define on your side, reading between the status reports, keeping your trial prioritized with every party, and resolving issues while they are still small.

Vendor management

Overseeing the full vendor chain, central labs, couriers, IxRS, EDC and more, including qualification, quality agreements and risk based oversight proportionate to each vendor's criticality.

Oversight monitoring & trip reports

Independent review of the CRO's monitoring: visit-report review, a direct line to the site teams, and quality-control site visits when needed, so you know what is really happening on the ground, and issues surface at the source, early, not only in a status report.

Supply & lab logistics

Trial product and samples in the right place, at the right time, with an unbroken cold chain. Including guiding site teams on sample processing and overseeing the labs, so every sample collected is a sample that can be analyzed.

03ProtectQuality, money and data that hold up

Quality & compliance

Risk based quality oversight, CAPA follow through and inspection readiness, so the trial holds up under an FDA, EMA or Ministry of Health inspection.

Contracts, rates & invoices

Experts in CRO and vendor contracts: we know the going market rates and negotiate on your behalf. And when the invoices start arriving in volume, we check each one against the contract and the work actually delivered, and approve only what was truly provided.

Safety & data integrity

Overseeing how the CRO handles safety events, queries and trial data, with ALCOA++ data integrity, so nothing is left open or unaddressed.

For CROs: raising your delivery

An experienced outside review of your processes, practical mentoring for your teams, and practical steps that lift the quality and consistency of the service you give your own clients.

“While sponsors can delegate clinical trial tasks to vendors, the ultimate responsibility for trial conduct, data quality, and participant safety remains with the sponsor.”

ICH E6(R3), Good Clinical Practice

An FDA, EMA or Israeli Ministry of Health inspection looks for exactly this, the documented proof that oversight actually happened, which is what turns independent oversight from a ‘nice to have’ into a real regulatory requirement.

ICH E6(R3) ISO 14155 FDA · EMA Israeli MoH
The outcome

On time, on budget, and built to last

On time

Issues surface early, so the timeline stays protected instead of slipping.

On budget

Fewer surprise costs and fires to put out, with the spend kept in view.

Built to last

Documented, inspection-ready quality the data can stand on.

Most clinical trials never make it to an approved product. Not every trial faces an inspection, but every trial has to succeed: on schedule, within budget, and at the quality the data depends on. Experienced oversight turns scattered status reports into one clear picture, so what matters surfaces early, the CRO and partners stay aligned to your priorities, the timeline and the spend stay protected, and the program stays ready for regulation when it comes. This is the layer that has been missing until now, and it meaningfully raises your chances of moving forward, all the way to an approved product.

Oversight protects your asset. To oversee and manage means: seeing problems before they happen, keeping every party on the same line, and making sure every dollar of the budget works. What you get out of it: fewer fires to put out, fewer surprise costs, a trial that stays on track, and results you can trust.

With us
  • Reports that tell you what actually matters, not noise
  • Tight, documented oversight that meets regulatory expectations
  • Problems caught early, while there is still time and budget to fix them
  • Quiet, steady operations across the CRO, the sites and every vendor
Without professional oversight
  • Green status reports that hide what is slipping underneath
  • Gaps in documentation that an inspection will find first
  • Issues that surface late, when they cost the most to fix
  • A CRO running on its own priorities, with the risk on you
Who it's for

Drug, biotech and medical device companies running a clinical trial in any phase, with or without a CRO. It fits teams that want an experienced hand on the study from the first decision, teams where the people running the study keep changing and continuity needs a steady anchor, and CROs that want an experienced partner to raise the level of their own delivery.

A first step, without commitment

Let us diagnose your trial

Before you submit

We review your protocol together, against the real operations of hospitals and research sites, before it is submitted. A small change now saves months and budget later. Then we select the CRO together, and run the negotiation, the terms and the contract with you.

Your trial is already running

A focused diagnostic: where the trial really stands against the plan, the budget and the CRO, what is at risk, and what to do tomorrow morning. You get a clear picture and an action plan, and you decide how to continue.

Short intro callFocused diagnostic of the protocol or the trialA clear picture and an action plan, in your hands
AI-based medical products

Building an AI-based medical product? Its safety still has to be proven in a clinical trial.

Safety evaluation and risk management of an AI-based system don't end in a regulatory file. Every AI-based medical device, diagnostic algorithm or digital health product eventually has to prove, in a real clinical trial, that it is safe and performs as claimed, with sites, patients, data and regulators. For AI products this trial has its own challenges: the quality of the data the algorithm is judged on, consistent collection across sites, and evidence that holds up to FDA and EMA review of AI-based products.

This is exactly the trial we oversee and manage. The same independent model, on your side only: choosing and managing the CRO, direct contact with the sites, structured measurement of every party's performance, and close attention to the data quality your algorithm's evidence depends on. For the regulatory strategy of the AI itself, its ISO 14971 risk files and software validation, we connect you to specialist regulatory partners from our network, and stay the one layer that holds the whole trial together.

An added advantage

How do you bring AI into a clinical trial the right way?

AI, embedded with judgment.

We help companies and CROs bring AI into their clinical operations the right way, mapping where it adds real value, choosing the right tools, and embedding them into the workflow so they strengthen quality and speed. Alongside this, we are developing Oversight AI, an internal tool that surfaces risk signals across CRO and partner data earlier and more consistently. Every decision stays human, documented, and accountable.

AI embedding & Oversight AI
Track record

Experience that drives CROs to perform

We don't replace your CRO. We give it the tracking, attention and escalation that turn chasing and surprises into a controlled, well-managed operation. The numbers below come from exactly that work.

Dozensglobal trial sites managed (US, EU, Israel)
Dozensvendors and subcontractors overseen, including CROs
$100k+in billing discrepancies caught, in a single trial
52%→93%a CRO's source data verification (SDV) completion, lifted in 8 weeks

The numbers above come from years of working on the company side of global Phase I–III trials, including oncology and FDA inspection support. The same oversight and management serve drug, medical device and digital health trials.

6 months to 1.5months to approve a protocol amendment, with tight oversight in place
The same principle applies regardless of indication or phase.
Safety queries, open for monthsOne safety case reached 13 follow-up attempts with no answer. Independent oversight forced real escalation, and items that had been open for 200+ days were finally closed.
A trial master file that looked complete on paperThe CRO's own quality checks on the TMF had quietly not run for two years, and no status report showed it. Meanwhile, the invoices for those checks kept arriving and being paid, even though the work was not done. An independent review caught it and drove the fix, before an inspection did.

And these are just two examples. Our trial diagnostic surfaces many more like them, in every indication and at every stage of the trial.

Keep control of your clinical trial.

Tell us about the study, and we'll show you exactly where experienced oversight makes the difference.

or send a message →
1:1 mentoring for clinical research professionals

Move up in clinical research, with people who have done every role in the field

Experience from every role in the field, on your side.

For CRCs, CTAs, CRAs and CTMs, for people in regulatory, QA and data, and for senior managers and independent consultants. Whether the goal is finding your next position, returning to the field, the next promotion, relocation abroad, or building an independent practice: professional, discreet accompaniment through the real meetings, emails and tough calls, until the next step in your career is truly yours.

or send a message →
Where are you right now?

Two tracks. Job search comes first.

Looking for your next role

Here is what nobody tells you: the traditional way, submitting a CV through the application systems, barely works anymore. Most good roles are filled through people, referrals and direct approaches, long before or instead of the system. We build a modern search strategy with you: sharp professional positioning, a CV and LinkedIn profile that pass both the screening systems and the humans behind them, direct access to the visible and the hidden market, interview preparation with someone who has sat on the hiring side, and salary negotiation, all the way to a signed offer.

In a role, and aiming higher

Discreet accompaniment while you work: the real meetings, emails and tough calls, building your professional presence, and structured preparation for the next promotion, in Israel or through relocation.

Every track in the field, from first role to VP and independent1:1
Clinical operationsCRA · CTM · project lead
Oversight & qualityOversight, QA, inspection readiness
Regulatory affairsSubmissions, compliance
Study start-up (SSU)Submissions, site activation, compliance
Data & safetyData management, pharmacovigilance
Senior leadershipHead of Clinical Ops · Director · VP
Independent consultantsFreelance CRA · consulting practice · pricing
NewEmerging rolesAI in trials · decentralized · RWE
Wherever you start, we help you find the right track and make the next move.
What we work on together

The parts of the job no SOP teaches you

Handling escalations

What to do when something escalates, and how to keep your footing under pressure.

Leading global meetings

Walk in prepared, and lead the room with quiet confidence.

Managing complex interfaces

Navigate the CRO, the vendors and the stakeholders without getting lost between them.

Asking the right question, the right way

Get exactly what you need without sounding unprofessional.

What truly matters vs what only seems urgent

Read priorities clearly and put your energy in the right place.

Professional English for clinical research

Not general English: the language of meetings, emails, status updates and global communication.

1:1
Personal, never generic
Discreet
Confidential by default
Network
Access to hiring managers & experts
Every track
Across the whole field
The field is changing fast

AI is reshaping our work. This is the moment to plan.

Manual work

The routine, repeatable tasks, increasingly automated.

AI steps in

Tools take over the repeatable parts of the work.

You rise a level

Reading risk, leading sites, and owning the judgment a model can't make.

This is exactly the moment to pause, look honestly at where you stand, and plan your next move with intent. That is what we help you do.

Breaking into the field

For those starting out: how to enter clinical research as a study coordinator or CRA, what employers look for, and how to stand out.

Growing your career

For those already in the field: moving from CRC to CRA to CTM and beyond, with a clear, realistic plan for your next step.

Stepping into oversight

For clinical operations professionals, at every level, stepping into a role that manages and oversees a CRO, including the independent oversight work at the heart of what we do. Personal mentorship so you lead the trial with quiet confidence from day one.

For senior professionals and managers

Senior enough to lead. Still human enough to want a thinking partner.

Seniority does not make the hard calls easier. Leading a larger team, standing in front of a board or a sponsor, making a decision under pressure with incomplete information, and staying ahead of AI and the changing regulation. This is discreet, one on one mentoring for people who are already senior, and want a sharp, experienced partner to think through the real situations with, in full confidence.

Leading teams and global stakeholders High-stakes decisions under pressure Staying ahead of AI and regulation
A senior clinical research professional reviewing trial data
How the mentoring works

Start small, see the value, then go further

No big commitment to begin. You start with one focused, affordable step that gives you something real to use right away. If it helps, and it usually does, there is a natural way to keep going.

1

A quick fit check

Free

A short, relaxed intro to see where you are and whether we are the right fit. Nothing to prepare, nothing to commit to.

Most popular
2

The Clarity Map

₪550 · start here

Your starting point, and the easiest yes. Together we map where you are, what is holding you back, what is really expected of you, and the moves that matter most right now. You leave with a clear plan you can act on straight away.

3

The Growth Track

Personalized · in the intro call

For when you want more than a starting point. An ongoing track where we work through the real situations you meet in your role, the meetings, the emails, the interfaces, the tough calls, the professional English, until the new way of working is truly yours. Tell us where you are and we'll shape it around you.

Mentoring focused on access, preparation and genuine effort on your behalf. What you get is clarity, confidence and better decisions in your role. The value is measured in the outcome.

Not sure yet? Just send a message.

Tell us where you are in your career. We'll start with a free fit check, and if it feels right, the Clarity Map is an easy first step.

or send a message →
The Network

A network that connects the entire field

Beyond consulting, Myrtle Clinical connects the people of clinical research, from the study coordinator at the site to the founder running the trial. Role based communities where everyone speaks openly with people who truly understand their world, because when the field communicates easily, better treatments reach patients faster.

A mentoring conversation between clinical research professionals around a table

For founders and CEOs of biotech, pharma and medical device companies. Everything you need to know about running and overseeing a clinical trial, learning from those who have walked the path.

Join group

For clinical operations professionals: CRA, CTA, CTM, regulatory, data management, quality, and anyone building a career in the field. Sharpen your knowledge, stay a step ahead, and open doors.

Join group

A professional space for study coordinators to share, consult and grow, with people who speak the same language.

Join group

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Learn · Clinical research courses

The key to entering and working in clinical research

Digital courses you take at your own pace, built on the ICH E6(R3) standard now in force, and on the guidelines that hold up to inspection.
At your own pace Internationally aligned certificate Built for Israel and abroad
The courses
Overview
  • GCP CourseThe entry point into clinical research, built on ICH E6(R3).
  • GCP RefresherKeep your certification current and move to ICH E6(R3).
  • CRA CourseThe monitoring track. Includes GCP, so you finish with two certificates.
  • Advanced coursesClinical operations, regulatory affairs, auditing, medical writing, data management and professional English.

Course length is shown in academic hours. One academic hour is 45 minutes.

Every course is built on the required standards:
The Israeli MoH procedure for clinical trials in human subjectsICH-GCP E6(R3)ISO 14155 for medical devices

In line with the training standard accepted across companies, hospitals and research sites in Israel and globally.

The gateway to the field

GCP Course

The entry course into clinical research, and the first step for anyone wanting to begin as a study coordinator or CRA. Built on the current ICH E6(R3) standard, and on what the leading programs in Israel and abroad cover.

Online, at your own pace 24 academic hours, including 4 hours of practical hospital training Built on ICH E6(R3), ISO 14155 & Israeli MoH standards Final exam, 85% to pass Certificate in English and Hebrew
More than the curriculum
  • Professional English, practised in context, so the language the field runs on becomes your advantage, not your worry.
  • Support from day one, all the way to your first job.
  • Optional interview preparation and help finding your first position, the hardest step to take when you are starting out.
01

Foundations of clinical research

  • The drug and medical device development path, and the trial phases (I to IV)
  • Types of studies and the language of the field, with the ICH E6(R3) glossary
  • Research ethics, the Declaration of Helsinki, and the rights, safety and wellbeing of participants
02

The ICH E6(R3) standard

  • The principles of Good Clinical Practice in the new R3 structure
  • What changed from R2 to R3, and what it means in the daily work
  • Quality by Design: building quality into the trial from the start
03

Roles and responsibilities

  • The ethics committee (the Helsinki Committee)
  • The investigator and the site team
  • The sponsor and sponsor oversight
  • The monitor (CRA) and the supporting roles
04

The protocol and the investigational product

  • The trial protocol and protocol amendments
  • The Investigator's Brochure
  • Investigational product management, randomisation and unblinding
05

Informed consent

  • Informed consent as an ongoing process, not a single signature event
  • The consent form, its documentation and the participant's comprehension
  • eConsent, and consent in remote and decentralized trials
  • Renewed consent after significant new information
06

Quality and data integrity

  • Risk based quality management (RBQM) and the critical to quality factors
  • Data integrity and ALCOA++ across the data life cycle, with audit trails
  • Essential records (the R3 term for essential documents), the Trial Master File and version control
07

Safety and pharmacovigilance

  • Adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR)
  • Causality and expectedness, and expedited reporting to the ethics committee and the regulators
  • Pharmacovigilance and the continuous safety monitoring of participants
08

Regulation in Israel and worldwide

  • The Israeli Ministry of Health procedure and submission to the Helsinki Committee
  • The FDA, the EMA and the international framework
  • Drugs versus medical devices, and ISO 14155
  • Inspection readiness: how a real FDA, EMA or Ministry of Health inspection runs
09

AI in clinical trials

  • What the FDA and EMA now expect when AI is used in a trial
  • How AI tools are used across trial design, monitoring and data review
  • Computerised systems and electronic records in a digital trial
10

From theory to the site

  • A required practical part for the certificate: a guided oncology department tour at a hospital in Israel, where the science meets the patient
  • Monitoring visits: preparation, execution and documentation
  • Real world case studies and scenarios from the field
A knowledge check after every module, a final exam at 85 percent to pass, and an internationally aligned GCP Certificate of Completion, aligned with the TransCelerate minimum criteria.
₪485individuals₪790companies
Get in touch
Most students go further: the CRA course includes this entire GCP course, adds the monitoring profession and a second certificate, and includes access to our professional community of over 300 clinical research professionals.
Monitoring trackMost chosen path

CRA Course

The practical track to becoming a Clinical Research Associate, the role at the heart of trial monitoring. It includes the full GCP course, so you finish with two certificates, and it is built on what the leading programs in Israel and abroad cover.

Two certificates: CRA and GCP 40 academic hours, including 4 hours of practical hospital training Built on ICH E6(R3), ISO 14155 & Israeli MoH standards Final exam, 85% to pass Certificates in English and Hebrew
01

The CRA role and the clinical trial

  • Who the CRA (monitor) is: the sponsor's representative at the site
  • The clinical trial from the monitor's point of view, and the trial phases
  • Where the CRA sits between the sponsor, the site, the investigators and the regulators
02

The standard the work is built on

  • ICH E6(R3) Good Clinical Practice and the monitor's responsibilities
  • The Israeli Ministry of Health procedure and the Helsinki Committee
  • FDA and EMA requirements, ethics and participant safety
03

The monitoring visits

  • The pre study visit: site selection and qualification
  • The Site Initiation Visit (SIV)
  • Interim monitoring visits during the trial
  • The closeout visit at the end of the trial
04

Inside the visit: what a CRA checks

  • Source data verification and source document review
  • The Case Report Form (CRF and eCRF) and query management
  • Informed consent verification at the site
  • Protocol deviations, findings and corrective actions (CAPA)
05

The trial at the site

  • The investigational product: the pharmacy, supply chain and drug accountability
  • Lab tests: types, values and fit to the protocol
  • Adverse events (AE), serious adverse events (SAE), SUSARs and expedited safety reporting
  • The Investigator Site File and the essential records
06

The modern CRA

  • Risk based and centralised monitoring
  • AI in clinical trials: what the FDA and EMA expect, and how the tools are used
  • Applied software, electronic documentation and remote monitoring
07

From theory to the field

  • A required practical part for the certificate: a guided oncology department tour at a hospital in Israel, where the science meets the patient
  • Running a monitoring visit: preparation, execution and documentation
  • Real world case studies and scenarios from the field
You finish with two certificates: a CRA certificate and an internationally aligned GCP Certificate of Completion, both issued in English and Hebrew. A knowledge check after every module, full viewing with no skipping, and a final exam at 85 percent to pass. You also get access to a community of more than 300 clinical research professionals.
₪1,600individuals₪2,500companies
Get in touch
Stay certified

GCP Refresher

For the move to ICH E6(R3), and for keeping your GCP certification current.

If you already work in clinical research, your GCP certification needs to stay current. Most companies and institutions renew it on a two to three year cycle, and many now require moving from the older R2 to the current ICH E6(R3) as soon as possible. This course is the clear, reliable way to update to R3 and keep your certification current, on your own schedule.

What the course covers
  • What changed in ICH E6(R3) and what it means in practice
  • Risk based quality management (RBQM) and data integrity
  • The Israeli Ministry of Health procedure
  • Knowledge checks after each module and a final exam

At your own pace, 8 academic hours. One certificate: an updated, internationally aligned GCP Certificate of Completion, in English and Hebrew.

₪250for everyone
Get in touch
Keep growing

More professional courses

A range of advanced courses for professionals in the field.

In today's field, the professionals who keep learning are the ones who move ahead. Every advanced course is built for the work as it is now, integrating the regulation and practice of AI in clinical trials, so staying current becomes the thing that takes your career forward.

  • Decentralized clinical trials and AI: data, regulation and execution
  • Clinical operations and trial management (CTM, Project Manager and senior roles)
  • Regulatory Affairs (RA)
  • GCP Auditor
  • Medical Writing
  • Data Management (DM)
  • Professional English for clinical research careers

One certificate per course, in English and Hebrew.

Company and individual pricing, shared on requestGet in touch
For anyone evaluating the course

Built to the standard regulators check

Every course is built on the Good Clinical Practice standard now in force, and on the guidelines inspections actually check. Here is exactly what stands behind it.

ICH E6(R3) Good Clinical Practice · the standard now in effect
Adopted by the FDA and EMA, 2025

Current ICH E6(R3)

The Good Clinical Practice standard now in effect, not the previous revision.

RBQM & ALCOA++

Risk based quality management and data integrity.

Inspection readiness

Prepared for FDA, EMA and Ministry of Health.

Israeli Ministry of Health procedure

The national procedure for running a clinical trial in Israel, with ISO 14155 for medical device studies.

Aligned with TransCelerate

Aligned with the minimum criteria for GCP training.

AI in clinical trials

What regulators expect, and how the tools are used in practice.

Online, at your own pace 85%to pass, on every chapter Knowledge check after each module Certificate in English and Hebrew
300+
clinical research professionals
More than a course

A community that has your back

More than 300 clinical research professionals, from study coordinators and CRAs to industry seniors, who share, support and understand one another. When you join a course, you can join them.

Join the community, free
The certificate
Certificate of Completion
Internationally aligned GCP Certificate of Completion
Aligned with ICH GCP E6(R3)TransCelerate minimum criteriaEnglish and Hebrew

A certificate that travels with you

Awarded on completion and aligned with the TransCelerate minimum criteria, an organization of the world's leading pharmaceutical companies, so you carry one consistent GCP certification across trials, in Israel and abroad.

It is issued in English and Hebrew, so it reads the same to a hospital in Israel and to a global CRO.

Our standard

To protect the professionalism of our graduates, every course requires full viewing of all chapters, with no skipping, and the certificate is awarded only on a score of 85 percent or higher on the exam at the end of each chapter.

The Myrtle Magazine Independent oversight, in writing

Field notes on clinical research

Practical knowledge across every stage of a clinical trial. Written for the people who run them, oversee them, and build careers inside them.

OperationsLead story

The most expensive color in clinical trials

A green status is not the same as a healthy trial. The detail you actually needed usually sits one layer below the summary.

Hadas Nachmanson · June 2026 ·

If you're a biotech founder running your trial through a CRO, this one is for you.

Status reports are built to roll up, to summarize, to reassure. That is not a flaw, it is their purpose. But it means the operational truth, the detail you actually needed, often sits one layer below what you are shown.

I have reviewed plenty of trials where the dashboard was green and the reality was amber. Not because anyone was hiding anything, but because the reporting smoothed the edges. Issues were aggregated. Aging was averaged. "Under control" quietly absorbed "open for three months."

The trial sponsor was not misled. They were not fully informed, by a system working exactly as designed.

Independent oversight is not about distrust. It is about cross checking what is reported against what is actually in the data, at the sites, and in the numbers.

The most expensive color in clinical trials is a green status that nobody verified.

Read below the summary. That is where the trial actually lives.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
Career

The real question is not how to get in, but where

Many talk about how to get into clinical research. Few talk about what happens next, and which path actually leads to the career you want.

Hadas Nachmanson·July 2026·

Many people share how to get into clinical research. Few talk about what happens once you are in.

Being a CRA (Clinical Research Associate) is demanding work: heavy load, targets, travel, huge responsibility, and sometimes the feeling that the effort is not really appreciated. And still, many stay in the role, because of the salary, the conditions, and the fear of giving up what they have already achieved.

So is the next step CTM? Not always. And moving to a sponsor company does not necessarily mean you have arrived: there are temporary roles, organizations that change with the phases of clinical development, and plenty of uncertainty.

And what if your dream is actually to be hired by one of the leading CROs? To many it looks almost impossible. Then the first day in the new role arrives, and suddenly there is barely any onboarding, you are expected to learn on your own, and within a few weeks you are already expected to work as if you had been there for years.

Moving from research coordinator into the industry is absolutely possible too. But the question is not only how to get in. The question is: where is the right place to get in? Because not every path leads to the career you actually want.

And in an era where AI and automation are already reshaping Clinical Operations, the choices we make today will shape our careers five and even ten years from now.

Sometimes the answer is not another course, not another version of the resume, and not another dozen applications sent without a strategy that end in another rejection.

Sometimes you need a senior person who knows the industry from the inside, who can guide you at every step.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
Operations

Running a clinical trial feels like chaos

Almost every biotech founder says the same thing. The problem is not that people work badly, it is that no single layer connects the whole trial.

Hadas Nachmanson·July 2026·

Almost every biotech founder says the same thing: "This trial is such a mess." And it does not happen at one company, it happens at almost all of them.

From the outside, a clinical trial looks like an orderly process: there is a CRO, there are vendors, there are sites, there is an internal team. On paper, everything is divided up. In practice, it all feels like one big chaos.

Why? Because responsibility for the trial did not really move to the CRO. The sponsor is still accountable for everything: the decisions, the logistics, the day to day activities that stay inside the company, the coordination, the vendors, and everything that happens between all of them.

At the very same time, the CRO works inside its own system, the vendors work through different interfaces, the sites are trying to get answers on time, and the company itself is trying to understand what it is even supposed to do day to day.

When there is no single layer connecting all of this, that is exactly what you feel: mess, chaos, loss of control. Not because people are working badly, but because there is no real connection between the parts.

One more critical point: many of the activities that stay with the sponsor are not fully clear from day one. So they get delayed, missed, or simply fall between the chairs under all the load.

At Myrtle Clinical, this is exactly where we step in. Not to replace the CRO, and not to replace the sponsor, but to place one layer above everyone that connects the entire trial into a single system.

In practice: you see the whole trial in one place. We connect the sponsor, the CRO, the vendors and the sites. We make sure the work that stays inside the company actually happens. We catch gaps before they become delays. And we turn the feeling of chaos into one coordinated system.

Because in the end it is simple: a clinical trial should not feel like ongoing chaos. It should feel like one system that works.

Do not cut corners on an independent oversight and management layer for the trial you are leading.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
Operations

Paying on milestones is not overseeing

Milestone payment proves a task was completed. It says nothing about whether the trial is being managed well.

Hadas Nachmanson·June 2026·

"We only pay the CRO when they hit the milestone." I often hear this framed as oversight. I see it differently.

Milestone based payment measures whether a task was completed. It does not tell you whether the trial is being managed well. It does not tell you why the same issue keeps reappearing every week, whether timelines are slipping because of weak execution or unrealistic resourcing, whether a site needs another study coordinator, whether the CRA is overloaded, or whether the protocol was ever made truly usable for the people expected to follow it.

And when payment becomes the main control mechanism, people focus on protecting the metric rather than openly surfacing what is actually going wrong.

Real oversight is not about making vendors work under fear. It is about understanding what stands between the trial and success, and fixing it. Sometimes that means escalation. Sometimes stronger accountability. Sometimes more support, clearer processes, better communication, or additional resources where they are genuinely needed.

The goal is not to catch the CRO. The goal is to make the trial better. Better managed, better supported, better controlled, and far more likely to deliver reliable results.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
Operations

Where your study really sits in the CRO's priorities

A strong CRO is the start. Getting its best execution for your trial is what independent oversight secures.

Hadas Nachmanson·June 2026·

Hiring a strong CRO is the start. Getting that CRO's best execution for your trial is what independent oversight secures. This is not about doubt. It is simply how outsourced delivery works at its best.

When a biotech, pharma or medical device company outsources a study, it transfers a large part of the budget and the execution responsibility to the CRO. From that point, the company depends on the CRO to drive sites, vendors, timelines and operational delivery.

So an important question arises: where does your study sit inside the CRO's priorities? CROs juggle many sponsors, studies, resource constraints and competing deadlines. Oversight makes sure your study gets the urgency, continuity and attention it deserves, and that everything stays visible, not just what surfaces on a weekly update call.

You usually read it between the lines: the pace of follow up, how quickly issues are resolved, CRA or project manager continuity, SDV recovery, whether vendor issues are driven to closure, and how strong site engagement stays.

Oversight turns payment into performance. The company understands exactly where its study stands inside the CRO's priorities, what to measure, and how to read between the reports.

That is exactly the kind of independent oversight that makes the CRO, the vendors and the sites work better for your trial, with stronger commitment, sharper focus, and clearer accountability.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
Operations

More efficiency, more fragmentation: why oversight is the missing piece

The industry is getting more efficient and more fragmented at once. Coordination is not control, and coordination breaks at scale.

Hadas Nachmanson·June 2026·

The clinical trials industry is becoming more efficient, but also more fragmented.

The FDA aligned ICH M15 guideline on Model Informed Drug Development is accelerating faster, data driven development in pharma and medical device companies. More efficiency means more programs, more trials, and more outsourcing to CROs and vendors. Not less complexity, more of it.

The direction is clear: more parallel development, more global execution networks, and more distributed responsibility. Accountability, however, stays with the company developing the product.

Execution is now split across multiple CROs, vendors and service providers. Each optimizes its own part. No one owns the full system.

This is why structured CRO and vendor oversight is the missing piece in most clinical programs. Not reporting. Not dashboards. Real operational control: quality, data integrity, protocol adherence, and alignment across every vendor.

Without it, there is no control. Only coordination. And coordination breaks at scale.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
Regulation

ICH E6(R3): the new standard for clinical research

Under ICH E6(R3), overseeing the CRO and vendors is no longer a recommendation. It is a regulatory requirement.

Hadas Nachmanson·June 2026·

On 6 January 2025, the updated Good Clinical Practice guideline, ICH E6(R3), was officially adopted, marking a major shift in clinical research.

The guideline came into effect in Europe on 23 July 2025, and the FDA adopted it in September 2025, with Annex 2 to follow.

Three key updates stand out. Risk based monitoring: focusing monitoring on the highest risk elements of the trial, for smarter resource allocation and better outcomes. Technology integration: embracing decentralized trials (DCT) and electronic data capture (EDC) to modernize trial management and protect data integrity. Stronger oversight: clearer requirements for accountability and regulatory compliance from every party, including vendors and CROs.

And what matters most for the companies developing the drug or device: under E6(R3), overseeing the CRO and vendors is not a recommendation, it is a regulatory requirement. The ultimate accountability for the trial always stays with the developing company, even when execution is outsourced. Structured, documented oversight is now part of regulatory compliance, not an optional extra.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
AI

The AI shift in clinical research: what it means for CRAs and for companies

AI is moving from drug discovery into the day to day running of trials, and reshaping the work faster than almost anyone expected.

Hadas Nachmanson·June 2026·

AI is moving from drug discovery into the daily running of trials, and it is reshaping the work faster than almost anyone expected.

For years, most AI investment in pharma sat upstream, in discovery. That has shifted. Agentic AI now reaches into trial execution itself: watching data across systems, drafting queries, flagging deviations, and surfacing the next best action. Industry estimates suggest a large share of routine clinical-operations tasks could be automated within the next few years.

What it means for the CRA. The parts of the role built on manual source-data review, query chasing, and report templating are the first to be automated. The CRA who thrives is the one who moves up the value chain: reading risk signals, coaching sites, deciding which deviations actually matter, and owning the human judgment a model cannot make. New titles are already appearing, from AI enabled CRA to digital trial manager. The role is becoming more analytical and less about volume.

What it means for companies. Adopting AI well is now a real advantage, and adopting it badly is a real risk. The questions that matter are practical: where does AI add genuine value, which tasks stay human, how is the model validated, and how do you keep every decision documented and accountable. Regulators are moving in step. The FDA published its Guiding Principles for AI in drug development in early 2026 and has begun deploying agentic AI internally, and the EMA has set out its own framework. The standard is clear: a human stays in the loop, and the rationale is always on record.

Where we come in. We help companies and CROs embed AI into clinical operations the right way, mapping where it helps, choosing the tools, and keeping quality and accountability intact. And we build it into our courses, so the professionals entering and growing in the field are ready for the work as it actually is now.

The shift is real, and it rewards the people and the companies who understand it early.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
AI

The AI model that's reshaping clinical trial design

Digital twins built with AI simulate the untreated patient, shrinking the control arm without compromising data quality.

Hadas Nachmanson·June 2026·

One of the most transformative technologies in clinical research today is the digital twin.

It marks a paradigm shift in how control arms are designed. AI powered models simulate how a disease would progress without treatment, so each participant in the treatment group can be paired with a personalized "digital twin."

Unlearn AI, a U.S.-based company, is leading the field, with its platform already applied in oncology and neurology trials. Its PROCOVA methodology received the first ever EMA qualification opinion for an AI methodology, and is aligned with the FDA's 2026 guiding principles for AI in drug development.

The technology uses historical clinical and biological data to generate synthetic control groups that closely mirror how patients would have responded without the investigational therapy. This speeds up recruitment by reducing placebo enrollment, shortens timelines, and reduces control arm size, without compromising data quality.

According to published data, control arm size can be reduced by roughly a third, Phase 3 recruitment shortened by up to four months, and full statistical power maintained.

Why it matters. For the developing company: faster, more efficient studies. For patients: greater access to advanced treatments, and a lower chance of being placed in the control group. For the industry: more ethical, data-driven trial design.

What is next? We may soon run trials that enroll only treated participants, while their digital twins generate the comparative data once provided by control groups. In 2026 the use is still largely supplemental and hybrid, but the direction is clear. The future is already here.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
Decentralized trials

Decentralized trials: no longer a trend, but today's reality

In a decentralized trial the patient no longer has to come to the site. For many companies, that is already the present, not the future.

Hadas Nachmanson·June 2026·

In a decentralized trial (DCT), the patient does not have to come to the research site.

Instead, a study nurse comes to the patient's home and performs everything the protocol requires: drawing blood, recording an ECG, completing questionnaires, and more. In some cases the study physician visits as well. All of this is possible today thanks to smart technologies.

COVID-19 was the turning point. Almost overnight it became clear that trials had to continue even when sites were closed and patients could not come in. Since then, with advances in AI and updates in global regulation, decentralized trials have rapidly become the emerging standard.

Above all, this model makes it possible to reach patients who until now were left outside research, breaking down barriers of distance, mobility and access.

But before getting there, the companies developing the drug or device need to ask themselves a few questions. Are you truly prepared to design a trial in a decentralized model? How will you collect and verify data remotely, including the work of CRAs in the field? And how will you manage so many parties at once from a distance, CROs, sites and patients? Because if reality forces you into this model, it is far better to discover it in advance, not in the middle of the trial.

Decentralized trials are no longer the future. They are the present. The only question is whether you will lead the change, or chase it.

By Hadas Nachmanson, Founder of Myrtle Clinical · LinkedIn
Career

Building a career in clinical research

Guidance and insights on entering and growing in clinical research, from first role to global responsibility, are coming soon.

In progress
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Want to write with us?

The Myrtle Clinical Magazine is open to clinical research experts who want to share their knowledge, reach a wide professional audience, and establish themselves as a leading voice in the field. If you have something worth sharing, we would love to feature you.

About

A serious home for clinical research, built on principles

Hadas Nachmanson, Founder of Myrtle Clinical

I'm Hadas Nachmanson, founder of Myrtle Clinical.

I have seen the clinical trial from every angle. I began at the hospital as a Clinical Research Coordinator, where the science meets the patient. I continued as a Clinical Trial Assistant in a global pharmaceutical environment, monitored data as a Clinical Research Associate, and managed global trials as a Clinical Trial Manager, on the side of the companies developing drugs and medical devices. A specialist in the operational and regulatory management of global clinical research, with extensive experience across every dimension of a trial.

Along the way I felt the gaps myself. The company rarely had a real line to the site, because everything ran through a CRO that did not always put its study first. With every move between roles, I had to work out the differences and the options on my own, with no one experienced to turn to, and face real situations without a discreet, experienced hand beside me. That kind of support would have changed everything for me.

I built Myrtle Clinical so that no company would have to run a trial without that kind of support. The experience is shared openly, with the companies bringing better treatments to the people who need them, and with the professionals building their careers in the field. Real, practical expertise, made available to everyone who moves a trial forward.

CRCCTACRACTMFounder & CEO, Myrtle Clinical
What we stand on

The principles behind everything we do

International regulation

Everything we do is grounded in the international standards. ICH GCP E6(R3) for drug and biotech trials. ISO 14155 for medical device investigations. What you get aligns with what regulators worldwide expect to see.

The most current knowledge

We stay aligned with the latest guidelines and industry developments, and bring that knowledge into every trial, course and consultation.

Oversight on your side

We oversee and manage trials from the side of the company developing the product, with full accountability for quality, timelines and control.

Connecting people

We make communication across the field simple, because when people connect easily, better treatments reach patients faster.

ICH E6(R3) ISO 14155 FDA · EMA

At the end of every protocol, every invoice and every data point, there is a single person waiting for a treatment that could change their life. They are the reason every detail matters. They are the reason I do what I do.

One standard: the highest, in every service.

Independent oversight and management of clinical trials, personal career mentoring, and professional courses, all built on the same field experience and held to the same professional bar. Tell us what you need, and we will tailor the way.

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