SERVICES
Why work with us
Neurotrials is specialized in the design and conduct of early phase clinical trials in neurology and psychiatry.
Neurotrials is based within the Paris Brain Institute, a European leader in neurosciences, itself located at the heart of the Pitié Salpêtrière University Hospital, a leading Hospital with an internationally renowned neurology department and a clinical investigation centre dedicated to neurological and psychiatric diseases.
This position grants Neurotrials a privileged access to Key Opinion Leaders (KOLs) in neurology and psychiatry and ensures their early involvement in the design of a clinical study.
01
Clinical Operations / Study Conduct
Neurotrials helps you design, start-up and manage your clinical trials to successful completion.
- Clinical operations activities : Site selection, initiation, monitoring, close out.
- Data management
- Biostatistics
- Pharmacovigilance
- Quality assurance
02
Scientific and Medical Consulting
Our highly scientific team provides you with the knowledge foresight and expertise to conduct your project
- Scientific consulting before starting clinical trials : Identification of product strenghts and weaknesses, refinement of scientific rational, product positioning (Target Product Profile, product development plan)
- Scientific advices
- Protocol design and clinical trial planning
- Develop key opinion leaders (KOLs) and advisory panel networks
03
Regulatory affairs
Our regulatory experts guide you through the entire product development to help you secure regulatory clearance.
Neurotrials provides strategic and operational support for regulatory activities and development of the documentation:
- Submissions to Competent Authority and Ethics Committee
- Response to agency reviewers
- Regulatory briefing documents for agency meetings
- Scientific Advice procedures and pre-submission meetings
- Orphan Drug Designation application
- ATMP classification application (GMO etc…)
04
Medical Writing
Our medical writing team supports the alignement of scientific objectives with sponsors, clinical sites and regulatory agencies
Neurotrials provides medical writing support for the full product‘s development, beginning with early-stage development:
- Synopses, protocols and amendments
- Informed Consent Forms and Patient Information Leaflets
- Clinical development plans, Clinical Study Reports (CSRs)
- Investigator Brochure
- Periodic and development safety update reports (PSURs and DSURs)
- Periodic benefit-risk evaluation reports (PBERs)
Neurotrials is part of a cutting-edge neuroscience research ecosystem. We bring you the best of the industrial and academic worlds to improve the development of your products.