The Project

The Project

How it started

GxPlex began with Florian Adragna, who started building his own reference database while preparing his international GCP courses.

As the corpus grew, it became clear it could be useful well beyond its original purpose, but turning a personal collection of references into a coherent, structured framework required untangling some genuinely difficult cross-jurisdictional questions.

That's where Ilse Tirry and Virgile Donet came in.

Their input helped resolve the trickiest points and gave the project a sound structure, one that made the whole thing readable, navigable, and interconnectable rather than just a long list of references.

What had started as one person's working tool became, through this collaboration, the foundation for something designed to be shared.

Florian Adragna

Florian Adragna is a freelance Clinical Research Associate and GCP Auditor based in Berlin, with a focus on oncology, vaccines, and pulmonology. He has worked in clinical research since 2014 and has been delivering GCP training as a freelance instructor since 2018.

Ilse Tirry

Ilse Tirry is a freelance clinical research consultant based in Belgium, with over 20 years of experience in clinical studies, including roles as Clinical Research Associate, Site Manager, and Clinical Study Manager across multiple European countries. She has particular expertise in medical device trials, alongside experience in pharmaceuticals, spanning therapeutic areas such as oncology, pulmonology, and gynecology.

Virgile Donet

Virgile Donet is a Medical Device Specialist and Consultant based in Nantes, France, with a background spanning clinical research, study coordination, and market development roles in the medical device industry.

Where things stand

The founding corpus already includes over 1,100 references, covering:

• International treaties and guidelines (ISO, ICH, WHO, and others)
• EU regulations and European guidelines
• National laws of Germany, Austria, and France
• National laws of the United Kingdom
• Federal laws of the United States

This is the starting point, not the finish line.

The aim is for GxPlex to grow well beyond what its three founders could gather on their own, through contributions from the wider clinical research community, including companies, consultants, clinical sites, and regulatory bodies themselves.

The vision

GxPlex is meant to become a natural starting point for regulatory questions in clinical research, a place where the answer to "what applies here, and how does it compare to there?" is easier to find than it has ever been, for everyone, not just those with the resources to dig it out themselves.

How to become part of GxPlex

GxPlex exists because people share what they know.

There are two main ways to get involved.

Become a Member (free)

Members are the heart of GxPlex. As a member, you can contribute references, add or edit entries in the database, and take part in the forum.

We're especially keen to hear from you if you can help with:

• Regulatory requirements from countries not yet covered in the database
• Regulatory requirements from other clinical research domains (beyond what's currently included)
• Regulatory requirements we may have missed that are relevant to a specific country or activity

Where to start

Every entry in GxPlex exists to answer a practical question.

When contributing, keep that in mind:

• a reference should point someone toward the answer they're looking for, not just exist for its own sake

Sometimes the clearest way to do that is to summarize where the answer can be found (for example, by listing the relevant paragraph titles), rather than reproducing a document in full.

We try to avoid simply copy-pasting whole laws into the database, even if some entries might look that way at first glance.

The listing of documents themselves, along with their scope and validity, is also a tool in its own right within GxPlex. Keeping this part accurate and up to date is just as important as the references themselves, and needs the ongoing attention and care of all members.

Not sure how to approach a new country or topic?

Two starting points:

   • A list of guiding questions to help you navigate the laws and guidelines of a new country systematically 
   • The table of content/Modules page, which lays out the existing themes/topics and shows where your knowledge might fit in

Become the Licensee

Beyond individual contributions, GxPlex is also looking for an organization willing to take on the licence for the platform, and take over its management going forward. This is a fit for an organization that:

1. Has the structure and resources to host, maintain, and develop the platform long-term
2. Shares the goal of keeping GxPlex's core functions freely accessible to the clinical research community
3. Wants to be associated with a resource that can grow into a reference point for the whole field, and is willing to invest in that growth

Taking on the licence means taking on stewardship of GxPlex's mission and its existing corpus, with the freedom to develop the platform further under the existing principles.

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