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== The Project == | == The Project == | ||
=== How it started === | |||
GxPlex began with [https://www.linkedin.com/in/florian-adragna|''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 [https://www.https://www.linkedin.com/in/ilse-tirry-9bb1757/|''Ilse Tirry''] and [https://www.https://www.linkedin.com/in/virgile-donet-a1616255/|''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. | |||
The | Â | ||
==== 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. | |||
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==== 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. | |||
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==== 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. | |||
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=== 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 | |||
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'''This is the starting point, not the finish line'''. | |||
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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. | |||
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=== 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. | |||
Revision as of 21:35, 19 July 2026
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.
