TEAM
Head of Neurotrials & Medical Lead
Dr Louise-Laure Mariani (MD, PhD)
Dr Louise-Laure Mariani (MD, PhD) is a Neurologist and Neuroscientist with a specialization in neuropharmacology.
She has an expertise in neurological disorders, such as Parkinson’s disease, other movement disorders, cerebellar ataxia and neurogenetics.
Associate Professor of neuropharmacology at the Pitié-Salpêtrière Hospital (Paris, Sorbonne University), and investigator in many international clinical trials.
She works in close collaboration with various French Reference Centers for neurological diseases.
Clinical Operations Manager
Pierre Georges François (MSc)
Pierre Georges François (MSc) has been working in the field of clinical development for 20 years, first in the pharmaceutical industry and CROs, before joining the Institut du Cerveau for the past 7 years.
Pierre began his career in CROs, where he held several positions, from CRA to senior project manager. He then joined IPSEN for more than 10 years, where he worked as a project manager and subsequently led multi-functional international teams responsible for managing clinical trials in various therapeutic areas: from Phase I “first-in-man” clinical trials to pivotal Phase III trials. Also at Ipsen, Pierre was an active member of cross-functional development program teams, representing clinical operations.
Key Positions at Neurotrials
Deputy Chief Scientific Officer
The Deputy Chief Scientific Officer assists the Medical Lead, providing expertise for scientific consulting, and for the development and review of clinical study documents, and contributing to the scientific excellence of Neurotrials. The Deputy CSO has advanced scientific training, an experience in preclinical and clinical research, and clinical trial management, and works in collaboration with the medical writer and Medical Lead.
Regulatory Affairs Officer
The Regulatory Affairs Officer provides regulatory advice and roadmaps, prepares and submits clinical trial applications, answers questions from regulatory authorities, and participates in the drafting and review of study documents. The Regulatory Officer ensures communication with the regulatory authorities, submits clinical study reports, is in charge of monitoring declarations relating to vigilance, and ensures Regulatory watch in collaboration with the Quality Officer.
Medical Writer
The Medical Writer centralizes and coordinates the writing and editing of various clinical study documents, including briefing books, study summaries, investigator brochures, informed consent forms, patient information, study manuals, protocols, and clinical study reports, while ensuring timely delivery. This requires research into therapeutic areas and products, review of medical and technical documents, and management of subcontracting activities for outsourced reporting. In Neurotrials, the Medical Writer has experience in clinical research and works in collaboration with the Deputy Scientific Officer and Medical Lead.
Quality Assurance Manager
The Quality Assurance Manager (QAM) is responsible for ensuring the implementation and updating of Neurotrials’ Quality Management System (QMS), ISO 9001 certified, training staff on Good Clinical Practices (GCP) and conducting internal and subcontractor/vendors audits. The QAM ensures customer satisfaction, manages the quality plans of the studies and ensures the compliance of the QMS with the current regulations. With scientific training combined with experience in clinical research, the Quality Assurance Manager carries out verifications (QC) related to the TMF, ensures the constant improvement of the QMS, and the regulatory watch with the Regulatory Officer.
Project Manager
Project Managers coordinate operational teams, vendors and sponsors contacts, manages the technical, operational and financial aspects of clinical studies, and ensures communication with sponsors and vendors. They are the first line contact and coordinator of all tasks related to study start up and operational conduct throughout all steps of the study. All project managers at Neurotrials have a solid scientific background and an experience in clinical project management.
Clinical Research Associates (CRAs)
Clinical Research Associates (CRAs) ensure the management of the investigational sites, perform the selection, initiation, monitoring and closure visits, as well as guarantee the compliance with protocols and regulations. They are in direct contact with sites to ensure the quality of the study.