The Sunnikan team

GEORGES MARTIN

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.

Raphaëlle KUHN

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.

Lobna MIFTAH-ALKHAIR

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.

Leire OLAZABAL

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.

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, mapped and rolled out the University Hospital's quality process for clinical research activities, coordinated various quality working groups and conducted clinical 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).

Meriem DHIB-CHARFI

Meriem DHIB-CHARFI, holds a PharmD in Pharmacy, a Master in Regulatory Affairs and also a university certificate in ATMPs management.

Meriem spent 7 years as Regulatory Pharmacist in pharmaceutical companies.

She then worked for 6 years as Quality Manager at the Clinical Research and Innovation pharmaceutical department of the Pitié Salpêtrière university hospital, where she successfully led the ISO 9001:2015 certification project, mapped and rolled out the University Hospital's quality process for clinical research activities and ATMPs management.

Meriem recently joined Sunnikan and now deploys her expertise in Quality, Process and Risk Management in clinical research.

Ghazi EL MASRI

Holds a MSc in Health Engineering and has been trained in pharmacovigilance by a specialized organization. He has occupied a pharmacovigilant position for 3 years and then worked as EuQPPV within a pharmacovigilance service provider. In addition to his operational pharmacovigilance missions (case management, literature monitoring, compliance monitoring), he was in charge of drafting the PSMF, procedures and SDEAs, and participated in pharmacovigilance audits and inspections as well as the implementation and monitoring of their action plans. Ghazi joined Sunnikan as a Pharmacovigilance Consultant in April 2020 and is involved in pharmacovigilance audits (more than 60 audits of corporate structures, affiliates, distributors, service providers…) and in the drafting and updating of pharmacovigilance procedures.

David MARCEREUIL

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 40 audits in Belgium, Bulgaria, France, India, Jordania, North Macedonia, Poland, Romania, United Kingdom.

From July 2021 at Sunnikan Consulting, David conducts clinical audits (investigational sites, study files (TMF), hospital pharmacies), and regulatory trainings (GCP ICH and France).

Amandine QUACH

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.

Annabelle SAILLY

Annabelle SAILLY, holder of a Master degree in "Biochemistry", worked for 4 years as Clinical Research Associate in a Clinical Research Center of Lille's university hospital.

Afterwards, she spent 16 years as Quality Manager at Lille's University Hospital, first at the Biological Resource Center, then at the Clinical Research and Innovation Department, where she successfully led the ISO 9001:2015 and NFS 96900 certification projects.

She also mapped and rolled out the University Hospital's quality process for clinical research activities, coordinated quality working groups and conducted clinical audits (processes and studies).

Annabelle recently joined Sunnikan and now deploys her expertise in Quality, Process and Risk Management in clinical research.

Pauline BENOIT-ISART

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.

Manon GERMÈS

Manon holds a Master II degree in Health Law and Governance from the University of Montpellier

Since 2021 at Sunnikan Consulting, Manon is involved in the production of the regulatory intelligence "Research involving the human person" "Genetically modified organisms" and "In Vitro Diagnostic Medical Devices". Manon also takes part in regulatory assistance services for our clients and is regularly involved as a Legal expert in services conducted by Sunnikan.

Clémence GUILLOT

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.

Soazic BARON

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.

Joana ISTE

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.

Pierre JOUBERT

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.