Risk based monitoring
Objectives of the group
Following the 8th Clinical Research Day (2019) and the Risk-Based Monitoring Workshop, a real need was identified on the implementation of RBM studies and practices used.
A dedicated working group has been created with the following objectives:
- inform and communicate about RBM, its regulatory context and its implementation;
- exchange on practice with all stakeholders.
Operation
- Introduction to RBM
- Sharing of experience on RBM technique and its application
- RBM in Investigative Centres
Actions
- development of communication tools: practical information sheets (reminder of FDA, EMA, Transcelerate regulations and recommendations; definitions and terminology, etc.)
- learning from each other
- organization and participation in dedicated events
Group Members
- Nathalie Amar – Kelly OCG ( host)
- Stéphane Hoppe – PRA Health Sciences (co-host)
- Fatima El Ghaib – KellyOCG
- Zakaria Maarouf – Kelly OCG
- Frederique Fauduet – Pharm Olam
- Alexandra Fursy- Axonal Biosatem
- Nathalie Giraud – PPD
- Benoit Gonzales – Medi-Link
- Margaux Gouysse – Clinigrid
- Yasmine Domingo –
- Josiane Ngomlonb- 4 Clinics
- Claire Lemaitre – Soladis
- Elodie Jadot – Soladis
- Isabelle Martin – RCTs
- Camille Motbal – Biofortis
- Yassine Omri – Keyrus Biopharma
- Anne-Claire Thieullin – Evamed
- Aurélie Vidal-Gonthier – Medpace
- Elsa Llobet-Merkling – Euraxi Pharma
Contact : groupe-rbm@afcros.com
Attractiveness
Acting with and with all stakeholders to make France an attractive country for Clinical Research
Medical devices
French expertise on the clinical evaluation of medical devices
Clinical Research Professions
Promote clinical research careers among students and professionals
Real world data
French expertise on real life primary and secondary data
Risk based monitoring
Support the deployment of Risk Based Monitoring
Patients and Clinical Research
Patients at the heart of clinical research
Regulatory
single convention
Monitor the use of the single convention
Regulatory
CPP-ANSM
Follow the regulations relating to study authorization requests
Regulatory
CNIL-RGPD
Follow health data protection regulations
Human vigilance
To develop and share good practices for the professional achievement of Clinical Research staff
Decentralised clinical trials
Reflections on the creation of an agile and secure methodology for the development of decentralised clinical trials in France.
Early access
Assessment and the implementation of early access