Clinical Strategy Design

/Clinical Strategy Design
Clinical Strategy Design Emmanuel Sanchez 2018-04-11T14:06:14+00:00

CLINICAL STRATEGY DESIGN

Activities related to the design of reference documents and other required documents are managed by the Project Manager who works closely with internal experts and a panel of external experts whenever necessary.

Reference documents design (Protocol, information notes and collection of consent, CRF …) new products, scientific communication, positioning, global approach :

  • Bibliographic research and literature analysis
  • Organization of meetings with experts (medical, methodology, statistic)
  • Planning and document drafting :
    • Protocol drafting :
      • Study objectives of the study and definitions of assumptions
      • Target population for the study : profile
      • Definition of selection criteria
      • Definition of evaluation criteria
      • Calculation of the number of subjects
      • Definition of data collection method
      • Feasibility and selection of participating countries and centers
    • Inform Consent Form
    • Patients questionnaire and Case Report Form (CRF)
    • Local adaptation of the Study Documents for international studies
    • Translation
    • Experts assessment and selection for other reference documents drafting : Investigator Brochure

Trials Master Files and Site Master Files design.