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26/09/2017
Témoignage d'un client de Keyrus Biopharma : Dr Segeant

Témoignage d'un client de Keyrus Biopharma dans le cadre d'une formation Affaires Réglementaire....

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Our Know-How

Feasibility and Project Management

Our Project Managers and Clinical Research Associates manage every step of your national or international projects.

They ensure that the research is compliant with Good Clinical Practice, ICH recommendations and local laws and regulations.

They will use your or our own Standard Operating Procedures as requested for the following services.

Project Management

  • Feasibility studies in France and abroad
  • Regulatory submissions (ethics committees and competent authorities)
  • Identifying potential investigational centres (phase I, hospital, doctor’s surgery)
  • Evaluation of the overall budget per investigator or activity centre
  • Estimation of timelines
  • Writing of the specifications manual
  • Management of confidentiality agreements, contracts, hospital agreements and extra costs
  • Writing of the consent form, patient's diary ...
  • Case report form (CRF) design
  • Creation of study documents (essential and regulatory documents, investigator file, trial master file...)
  • Management and logistics of the study materials (products, biological kits ...) and study documents (printing, mailing ...)
  • Management of invoices and investigators’ fees
  • Communication: organisation of meetings (Investigator, CRA), newsletters
  • Coordination of the different contributors to the project (central laboratory, data management, IVRS, biostatistics, medical writing etc.)
  • Regular reporting to the client

Monitoring

  • Selection of Investigator centres
  • Creation of monitoring tools and status tables (regulatory documents, recruitment, monitoring visits, adverse events, etc.)
  • Initiation, monitoring and close-out visits and preparation of visit reports in French or English
  • Management of serious adverse events (SAEs)
  • Query management
  • Contact with the Investigator site teams (hospital unit, pharmacy, local laboratory)