An integrated team of expert consultants
Sunnikan brings together an integrated team of pharmacists, scientists, engineers, health law experts and a doctor. A team of ten consultants at your service, with specialised experience and expertise in all clinical quality management fields.
Our consultants take on a host of different roles, from advisers and clinical quality managers, to pharmacovigilance quality managers and international auditors...
Each project is rolled out based on shared working methods developed specifically by Sunnikan and supervised by a Senior Consultant.
The diversity of the projects we work on, as well as the range of different clinical trials and clinical process steps we've worked on means Sunnikan consultants are continuously learning and re-training in line with changes to regulations, in a bid to develop cutting-edge expertise across the board.
Founder and director, Doctor of Medicine and engineer
Clinical research, Epidemiology, Regulatory issues, Biotechnology, IT system validation
An aeronautical and aerospace engineer and Doctor of Medicine by training, Georges joined the pharmaceutical industry at the IPSEN Laboratories followed by the Institut Henri Beaufour as Head Clinical Research Physician working on Phase 1, 2 and 4 trials.
He shifted his focus over to process and quality management at Bristol-Myers Squibb and then at Bayer Pharma, where he and his team were the very first to ever receive ISO 9001 certification in clinical research.
Following on from his responsibilities as European Director for Medical Issues Quality Management for European Medical Affairs at Bayer, he founded Sunnikan in 1996.
Pharmacovigilance, Clinical research, Regulatory issues
Frédérique is a Doctor of Pharmacy and has a DESS in Pharmaceutical Quality Assurance.
She first worked with Dr Georges Martin 20 years ago at Bayer, where she was QualityAssurance & Methods Project Manager.
Frédérique joined Sunnikan 15 years ago and covers Sunnikan's core areas of expertise: clinical research and pharmacovigilance. Her experience and skills mean she runs training sessions, leads multi-disciplinary working groups in rolling out quality management systems, oversees quality management for client accounts, carries out audits (over 150 audits to date), inventories, diagnoses and inspection preparations.
Clinical research, Epidemiology
Lobna has a Master's in toxicology- and pharmacology-directed biology and a Master's in Pharmaceutical Quality Assurance (Université Paris Descartes).
Having joined Sunnikan in 2011, Lobna works on drafting procedures (clinical research, data management, statistics), audits (investigation centres, studies, suppliers, etc. with over 70 audits carried out to date), implementing quality systems (supporting a CRO through being granted ISO 9001:2008 certification) and training.
Pharmacovigilance, Safety of clinical trials
Doctor in pharmacy. Raphaëlle worked as a pharmacovigilance specialist at the CRPV in Saint-Etienne, before spending 18 months with Sanofi Pasteur's Global Pharmacovigilance Department, working on the quality control of individual case safety reports, regulatory monitoring in pharmacovigilance, procedure drafting and training new recruits.
Raphaëlle also worked at the EMA on the "Good Pharmacovigilance Practices (GVP)" drafting project and in clinical trial safety at the Hospices Civils de Lyon.
Raphaëlle joined Sunnikan in 2012, where she mainly works on pharmacovigilance and clinical trial safety projects: drafting procedures, training, audits (over 150 audits conducted in France and abroad), and pharmacovigilance inspection-readiness.
Raphaëlle is also in charge of the regulatory monitoring in pharmacovigilance for France and for editing the monthly Safety Observer newsletter in partnership with PV Focus.
Clinical research, Epidemiology
Leire has a Master's in Biochemistry (Université Paris VII) and a DESS diploma in Quality Assurance (Université François Rabelais, Tours).
Leire spent three years working as a Quality Assurance Director in a phase 1 investigational site, where she led an ISO 9001:2000 certification project.
Leire then spent 10 years at Bordeaux's University Hospital at the Clinical Research and Innovation Department as Quality Manager, where she successfully led the ISO 9001:2015 certification project (November 2016), mapped and rolled out the University Hospital's quality process for clinical research activities, coordinated various quality working groups and conducted quality audits (processes and studies).
Leire joined Sunnikan in 2017 and is tasked with implementing/reviewing quality systems, drawing up procedures, auditing (systems, studies, investigation sites, suppliers, etc.) and training.
To date, Leire has conducted over 100 audits (in France, Moldova, Peru, Mexico, Tunisia, Russia, Thailand and beyond).
A legal expert with a Master's in biotechnologies and law (Université François Rabelais, Tours), Pauline joined Sunnikan in 2017 and assists with the company's regulatory monitoring: 'Research With Human Subjects' and 'GMO', in addition to providing regulatory assistance.