Interview with Géraldine Mercier
The role of a Head of Biometry
“In data management, we are technical experts, we develop specific databases to collect and verify patient data according to the protocol approved by the health authorities.”
What is your job position and how would you define it?
I’m the Head of Data Management and Clinical Programming. I provide management, mentoring, and leadership to the data management, database, and clinical programming teams. In data management we are technical experts, we develop specific databases to collect and verify patient data according to the protocol approved by the health authorities. We are the guarantors of the clinical data collected to prove the effectiveness of treatments for patients. I’m responsible for defining and implementing the strategy of the global data operations to support clinical research.
“We are the nerve centre of a clinical trial because we work with all the other departments as well as with external vendors such as central laboratories, central ECG or imaging. “
Geraldine Mercier, Head of Biometry
What is your expertise area?
I have more than 28 years of experience in epidemiologic and clinical research. I started my career as a Biochemist in a Laboratory where I was in charge of developing protocols in molecular biology, epidemiology and genetics. We were looking for relationships between genetic mutations and diseases. I participated in the writing of 45 scientific publications. As I was interested in the management of clinical data, I moved to clinical research in Data Management and became an expert in Clinical Data Management Systems and data management.
When does your expertise come into the product’s life cycle and why is your job position relevant at Aixial Group?
My expertise covers all phases of product development because at every stage it is necessary to collect and verify clinical data. Me and my team support sponsors in collecting high-quality data to support their product development strategy.
The Head of Data Management has an essential role as it ensures that the tools used to collect the data (called EDC) are used efficiently and safely and that the data are processed appropriately to guarantee compliance with the protocol and good clinical practices.
How does your job or area of expertise stand out in the CRO industry?
My area of expertise stands out by the fact that clients have confidence in us and our know-how. They know that their studies are in good hands and that we will deliver excellent quality to support their development objectives. You’ll get regular customers, which is the main indicator of success in the CRO business.
What would you say are some challenges or trends that are impacting or will be impacting your area of expertise?
Clinical trials are evolving in response to new trends, which involve reducing trial costs and monitoring patients at home as often as possible. We therefore need to design different processes that adapt to these changes, but also tools that respond to them.
When it comes to data management, there are many challenges, and as I said, technology evolves, and we must keep up with new trends. Teams need to be trained in the new tools and processes so that they can continue to meet customer expectations in this area.
