Management and Evaluation of Therapeutic Trials GET

Our aim is to train managers in the healthcare field, responding to emerging needs and demands in the areas of clinical drug evaluation, regulatory aspects of marketing and neuropsychology. We train for clinical research professions with both industrial and academic outlets: Clinical Trial Coordinator, Clinical Research Associate, Quality Manager, Project Manager Physician or Pharmacist, Regulatory Affairs Manager and Clinical Research and Development Engineer.

In the field of neuropsychology, we offer a range of career opportunities, including executive health researchers, specialized research associates and managers in care facilities for the elderly.

Master 1:

The program enables students to acquire an initial specialization in one of the two fields related to each of the two Master 2 courses.

It provides the prerequisites in methodology, biostatistics, quality assessment and neurophysiology in one of the 2 areas of specialization: design, evaluation and management of therapeutic trials, neurophysiology and anatomy, necessary to acquire the dual competence with project management offered by the Masters 2 "Design, Evaluation and Management of Therapeutic Trials" and "R&D Neuropsychology".

Master 2 :

This course complements the scientific and technological training acquired in Master 1, by providing the dual skills in clinical development and methodology needed to enable our young future managers to integrate quickly and successfully into industry, regulatory agencies, clinical research departments and the ageing professions. Our aim is to train executives in the healthcare field, responding to emerging needs and demands in the fields of clinical drug evaluation and regulatory aspects of marketing, at both European and national levels. Professionals are involved in the valorisation, quality, preclinical development and phase 2/3 studies of drugs and biotherapies. The program's professionalism and focus on graduate integration in the public and private sectors are underpinned by strong interactions between hospital departments, researchers and neuropsychology professionals. There are no regional programs offering this dual skill set.

The aim of the "R&D Neuropsychology" Master 2 program is to acquire dual skills in neuropsychology and project management, through theoretical (fundamental and clinical) and practical training. This neuropsychology course will enable students to apply their knowledge of the biological, neurophysiological, neuroanatomical and clinical foundations of normal and pathological cognitive and behavioral functioning to their professional practice in the fields of health, medical-social care, research and industry, while mastering project management and quality control techniques. This training enables students to acquire research and development skills in neuropsychology, a skill now required for new job opportunities linked to growing needs (aging population) and the constant expansion of certain activities (medico-social, healthcare and pharmaceutical industries, service providers) in the field of cognition and behavior.

On completion of the internships and the "Design, evaluation and management of therapeutic trials" or "R&D Neuropsychology" training courses, students should be able to:

- Contribute to the design and preparation of a test.

- Contribute to the drafting of a clinical trial protocol.

- Prepare the regulatory file for biomedical research to be submitted to the CPP and competent authorities.

- Contribute to the management of a clinical trial - set-up and follow-up.

- Participate in the selection, opening and closing of biomedical research centers

- Evaluate the adequacy of the forecast schedule, particularly in terms of inclusion capacity

- Participate in drafting standard operating procedures (SOPs) and ensure compliance with GCP and the quality assurance system during a trial

- Manage study documents, set up and update an investigator file in compliance with regulations

- Participate in the pharmacovigilance follow-up of a trial (reporting and follow-up of G.I.E.s, management of consequences on project progress).

- Participate in the coordination of multicenter studies

- Prepare data checks (audit or inspection)

- Archive study documents

- Contribute to the evaluation of a clinical trial

- Assessing a biomedical research project from a regulatory standpoint

- Participate in the evaluation of biomedical research costs and prepare a research budget

- Critically analyze the methodology and results of an article reporting the results of a clinical trial

Objectives specific to the specialization: scientific and professional orientations of the training program.

Pedagogical objectives

On completion of the specialization, students should be able to :

- List the main sections of a clinical trial protocol

- Writing a clinical trial protocol

- Argue the methodological options adopted in a clinical trial

- Specifying the regulatory framework of a clinical trial

- Outline the clinical trial dossier to be submitted to the CPP and the competent authorities

- Recall the principle and key points of GCP and of a quality assurance system in the context of a clinical trial.

- Explain the principle of pharmacovigilance in a clinical trial and describe the tools used to evaluate it.

- Defining the roles of the various players in a clinical trial

- List the expenditure items in a research budget

- Assessing the costs of biomedical research

- Analyze a biomedical research project from a regulatory standpoint

- Critically analyze the methodology and results of an article reporting the results of a clinical trial

- Give a synthetic oral presentation of a clinical study protocol in French and English