Clinical studies

– Planning of regulatory affairs activities.
– Development of various projects/strategies allowing optimization in the regulatory field.

– Research involving humans (medical devices, medicines, cell therapy, etc.).
• which involve an intervention on the person not justified by their usual care
• “which do not involve medication and only involve minimal risks and constraints”.
– Randomized trials.

– Pharmacoepidemiological, retrospective, prospective, transversal, longitudinal studies.
– Data research.
– Biological collections
– Pathology observatories.
– Post-MA studies requested by Health Authorities.
– General population surveys.
– Pharmacoeconomic studies.
– Studies of use and practices.

– Bibliographic search.
– Request for proposals from subcontractors (printing, phoning, etc.) and quality control.
– creation of the graphic charter and a logo.
– creation of documents (Protocol, CRF/eCRF, patient questionnaires, TMF, ISF, PPT presentations).
– regulatory submissions CNIL, CNOM, CPP, ANSM, CCTIRS.
– Organization, management and animation of expert boards.
– preparation of investigator/expert contracts.
– Feasibility / pre-selection of centers (creation of mailing/phoning script).

– Training of the dedicated team and investigative centers in the study protocol and eCRF.
– Preparation and sending of study kits.
– Management of investigative centers and regular communications (emails, phoning, newsletters).
– Monitoring of the study via an Access or internet database.
– Identification of problems and rapid resolution in a transparent manner.
– Monitoring of centers/pharmacies.
– Query management and updating of the eCRF.
– Management of pharmacovigilance and transmission to the dedicated PV service on time.
– Management of fee notes and payments.
– Audits of investigative centers and ARCs.
– Regular reporting to the client (progress status).
– Management of monitoring reports.
– Collaboration with the international team and participation in telephone meetings.
– Compliance with the forecast schedule.
– Update of the TMF and ISF of the study
– Management of the closure of centers and pharmacies.

– Collaboration with biometrics
– Writing statistical and clinical reports (ICH format), abstracts and posters