The functional structure of the group is in essence very similar to the structure encountered in the pharmaceutical industry. Only few variations have been implemented in order to fulfil the specificities of the group.
* Management: The Group is headed by its General Director, Dr Herve Karsenty, and its Director of Operations, Mrs Nelly Rémond. Strategic decisions involve also the Board of Directors which includes also the Manager of Business Development, Mr Sébastien Thépenier, The Director of Key Projects and IT, Mr Bruno Voulaz, the Senior Clinical Project Managers, Mrs Stéphanie Leclerc and Mrs Sophie Perrin-Brutto, and the Director of QA, Mrs Christel Souillard-Maudet. The Board of Directors meets formally every semester to define major orientations of the group which comprises approximately 95 people as of today.
* Monitoring: Monitoring includes both clinical monitoring and site assistance. 7 Group Managers are under direct responsibility of the Director of Operations. Each Group manager has 3 to 6 CRAs under his/her responsibility. The monitoring group represents a 40 people department.
* Data Management: Headed by Mr Laurent Bertel, Data Management comprises 2 Data Managers/Programmers. One Coding specialist is responsible for the management and use of major data dictionaries. In addition, data entry personnel are under direct supervision of this group. This department liaises with IT development which has responsibilities on programming and maintenance of randomization servers.
* Biostatistics: Biostatistics is headed by Mrs Murielle Gagneau, who drives a total of 5 statisticians. This group is also directly involved in clinical writing activities together with the medical group.
* Medical and Regulatory Affairs: This department includes 5 Doctors in Medecine and 3 a number of Clinical Coordinators. This department is responsible for pre-study regulatory affairs, medical support and pharmacovigilance, and is involved in clinical writing activities together with the Biostatistics department.
* Quality Assurance: QA is headed by Mrs Christel Souillard assisted by 2 QA officers. Quality Assurance reports to General Director.
* Administration: Administrative functions include general administration, finance control, accountability functions and secretarial support. Administration reports directly to the General Director.