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 Chairman, Senior Consultant, Pedagogical Officer, Doctor of Medicine and engineer
Quality, Process and Risk Management, Clinical Research, Epidemiology, Regulatory Affairs, Biotechnology, Computerized System Validation
Aeronautics and aerospace engineer and a doctor of medicine, Georges joined the pharmaceutical industry at IPSEN Laboratories and then at the Henri Beaufour Institute, as a Clinical Project Manager working on phase I, II and IV trials.
He moved to quality and process management at Bristol-Myers Squibb, then at Bayer Pharma where he and his team obtained the world's first ISO 9001 certification in clinical research.
After serving as European Quality Management Manager at Bayer Medical Affairs Europe, he founded Sunnikan in 1996.
Pharm D., Senior Consultant
Clinical Research, Epidemiology, Safety of clinical trials GCP Mock-inspections
Philippe holds a PharmD in Pharmacy and a University degree in Clinical pharmacy in oncology.
Philippe has multiples work experiences in both the Pharmaceutical Industry and Competent Authorities. As part of these experiences, he was actively involved in the assessment of health products as well as in marketing authorisation dossiers.
Since 2019 at Sunnikan Consulting, Philippe has been performing clinical quality management support (consulting, procedures writing, regulatory inspections preparation, management and follow-up,...), audits (systems, studies, investigational sites, vendors (CROs, CSOs, CMOs, Central laboratories, Central reading), computerized systems validation,...), mock-inspections and trainings (Good clinical practices, EU Regulations 536/2014, 2017/745 and 2017/746, Jardé Act, etc.).
Philippe is based in Tours - France.
Pharm.D., Senior Consultant
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, ISO 9001, Data protection
Lobna has a Master's in Biology oriented to toxicology- and pharmacology and a Master's in Pharmaceutical Quality Assurance (Université Paris Descartes).
Lobna joined Sunnikan in 2011 and since then, has performed over 180 audits worldwide: system audits (quality, project management, monitoring, data management, statistical activities, benchmark methodology MR006…), service provider audits (qualification, follow-up), investigational sites.
Lobna provides also consultancy services for setting-up and/or maintaining quality management systems (including drafting and review of standard operational procedures and related tools and templates, training and management of CAPAs).
For several clients involved in clinical research activities (either interventional or non-interventional), she coordinated the implementation of an ISO 9001 approach for their quality management system that let to obtaining and maintaining their certification.
She also performs trainings on applicable regulatory requirements for clinical research, including GCP trainings.
Marie-Noëlle, Consultant, holds a Bachelor degree in Biology, a Master degree in Biomedical Technology and a University Diploma of “Quality Auditor in Pharmaceutical Industry”.
Marie-Noëlle worked for more than 20 years at GSK laboratories as a Clinical Research Associate and Clinical Trials Manager in different therapeutic areas. She enriched her experience in clinical research by joining a CRO specialized in nutrition and health in 2011 for which she held the position of Clinical Team Manager and then in 2016 becoming Director of Clinical Operations in a biotech conducting trials in the regulatory frameworks of medical device and drug.
Marie-Noëlle joined Sunnikan Consulting in January 2023 and now deploys her expertise in audits, consulting, trainings, and clinical quality management support.
Clinical Research, Epidemiology
David holds a Master in Pharmacology and in Biochemistry. He also holds a University Diploma of “Quality Auditor in Pharmaceutical Industry”.
David worked for 17 years in a Belgian pharmaceutical company, sponsor of clinical trials. He started as a clinical trial coordinator, managing phase I to III trials being involved in the medical writing of essential documents (protocol, investigator’s brochure and study reports) while managing the contract research organizations involved in these trials.
After 6 years as a coordinator, David moved to quality assurance management. He took over the maintenance and update of the quality system, ensured the regulatory intelligence, the trainings related to these two activities, the establishment of the audit planning and their conduct (audit of investigational sites, studies, contracted research organizations. To date, David has performed about 80 audits in Belgium, Bulgaria, France, India, Jordania, North Macedonia, Poland, Romania, Spain, Switzerland, United Kingdom.
From July 2021 at Sunnikan Consulting, David conducts routine and for-cause clinical audits (investigational sites, study files (TMF), hospital pharmacies, CROs, CMOs, Central laboratories, computerized system validation), clinical quality management support (consulting, quality documents writing / review) and regulatory trainings (GCP ICH and France).
Clinical Research, Epidemiology
Scientist, got a Master II degree in Public Health "organisation des soins et des systèmes de santé" from the Paris Sud University, and a Clinical Research Associate training (Institut Léonard de Vinci). Amandine worked for almost 4 years as a Clinical Research Associate in a worldwide CRO (becoming Senior CRA in 2018).
Since 2019 at Sunnikan Consulting, Amandine has conducted clinical audits (investigational sites, Trial Master Files, sites' pharmacies, Sponsors and Vendors' qualification – over 40 audits carried out to date) in France and in Europe, provided trainings and has written / revised quality documents.
Holds a Master 2 in Development and Clinical Research.
After obtaining a Bachelor's degree "Sciences pour la Santé" and a Master 1 "Biologie Santé" in Fundamental Research, Jeanne specialized in Clinical Research with this Master's degree, which she completed in a work-study programme at the Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) as a Clinical Research Associate.
Since November 2022, at Sunnikan Consulting, Jeanne has been carrying out clinical trial audits of investigation sites.
Chief Legal Officer, Legal Expert, Senior Consultant, Data Protection Officer
Clinical Research, Epidemiology, Data Protection Agreements
A legal expert with a Master II degree in Biotechnologies and law (Université François Rabelais, Tours) and a Master II degree in Health Law (Université Paris 8), Pauline joined Sunnikan in 2017.
Pauline is in charge of the regulatory intelligence related to " Research Involving the Human Person " and "Genetically Modified Organisms" and is involved in the development of the new "In Vitro Diagnostic Medical Devices" intelligence service. She also takes charge of regulatory assistances for Sunnikan' s clients (almost 175 regulatory assistances). She coordinates the implementation of data protection regulations for our clients, provides trainings, is in charge of the regulatory compliance of standard operating procedures and related documents (templates, checklists, forms) and is regularly involved as a Legal expert in services conducted by Sunnikan. She performs audits in data protection (MR-006).
As Chief Legal Officer, Pauline coordinates the work of the Legal Department and is in charge of contractualisation process for the services performed by Sunnikan Consulting.
As Data Protection Officer, she is in charge of Sunnikan Consulting's data protection compliance.
Legal Expert, Consultant
Clinical Research, Epidemiology, Data Protection
Holding a Master II degree "Health Law" (University of Tours) and a Master I degree in "Health and Social Law" (University of Poitiers).
Clémence joined Sunnikan Consulting in 2019 in the Legal Department and collaborates on the production of the regulatory intelligence "Research Involving the Human Person" and "Genetically Modified Organisms". She is also developing the new "In Vitro Diagnostic Medical Devices" intelligence service. Clémence is in charge of regulatory assistance (nearly 100 projects) and participates in regulatory compliance of Sunnikan's Clients related to data protection. She is also regularly involved as a Legal expert in services conducted by Sunnikan (standard operating procedures, document templates, checklists, audits, ...). She develops training tools (update and creation) on regulations as well.
Management of projects and client missions, Coordination of the Training Department, Internal business processes
Holder of a professional degree in Chemical and Pharmaceutical Industries, as a Laboratory Technician, with the Centre d'Études et de Recherche en Cosmétologie - C.E.R.CO. (YVES ROCHER Group). She worked for more than a year for L'ORÉAL Research & Innovation as a Scientific Assistant. After training as a Clinical Research Associate at Advanced Drug Development Services - ADDS, and having been an intern at Guerbet, she joined Sunnikan Consulting in 2008 as a Project Manager to provide logistical and administrative support. Today, as the Administrative Project Manager, Soazic ensures a coordination role between all actors at Sunnikan. She is in charge of updating the information system, preparing contractual documentation and monitoring invoicing with the Senior Consultants, improving methodologies, processes and internal documentation with the Quality Manager, and managing regulatory watch subscribers with the Legal Department. Finally, Soazic has recently completed all the steps with the Pedagogical Manager and the rest of the team in order to allow Sunnikan to meet the requirements of the Qualiopi certification, guaranteeing quality training.
Administrative and accounting tasks, Administrative management of training courses, Business travel
Joana has joined the Sunnikan team since September 2018. Enriched by 7 years of experience in a consulting firm, Joana has a transverse function within the company. In particular, she is in charge of reception, assisting the manager and consultants in their daily work, participating in the improvement of the service rendered to customers by Sunnikan, taking care of part of the administrative and accounting tasks, without forgetting all the administrative management of training.
ISE Engineer, Systems and Network Administrator
IT system administration, Computerized System Validation
Holds a degree in Industrial Systems Engineering. Since 2007, at SUNNIKAN Consulting, Pierre manages the administration, the development and the optimization of Sunnikan's Information System, while occasionally intervening on other missions: audits (of system, service providers…), writing of procedures (quality, IT development, security, data management, statistics...) and training.