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Clinical Research

 
 

Experts' meetings

Identification of (clinical) experts, preparation,
  organisation, and delivery of meetings
Identification of experts (from regulatory
  authorities); preparation, organisation
  and delivery of meetings.

Feasibility studies

Identification of opinion leaders
Identification of investigators and centres
Evaluation of costs
Evaluation of time scales

Development plan

Clinical development plan:
  advice and design services
Regulatory strategy:
  advice and design services. 
 

Investigator brochure

Design

Protocol

Writting and design

CRF

Design
Writing
Lay-out, production

Study documentation

Design
Writing
Lay-out, production

Translations

Submission to authorities

Preparation and submission of clinical
  reports to Ethics Committees
Preparation and submissions
  to medicines agency: 
  applications for import licence
Preparation and submission of clinical project
  to the national commission for protection of
  liberties in IT Preparation and submission of
  dossier to the national association of doctors