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Principal Investigator: Jaakko Tuomilehto & Rafael Gabriel


Brief description:

EVIDEM CONSULTORES SL was created in 2001 and has developed consultancy and services work for the pharmaceutical industry and scientific societies in Spain and at International level, particularly in designing, coordinating and analysis of clinical trials and epidemiological studies


Main tasks attributed:

Lead coordinator of:

WP01 Global Project coordination

  • Project management and Institutional relations.
  • Prepare the final protocol in the CT format required to be submitted to the local/national ethic committees of all participating state member countries and monitoring for compliance with ethical standards throughout the Project.
  • To prepare all needed material to be submitted to local and European medicine agencies for final approval of the clinical trial.
  • Coordinate Interaction and scientific interchange among project investigators.
  • Organization of scientific and periodic coordination meetings.
  • Act as the sponsor of the trial
  • Establish the whole clinical research plan and follow-up (Steering Committee, Ethics Committee, Data and Safety Monitoring Board) and communication and dissemination activities.

WP02 Coordination of Clinical Centres Works

  • To Develop the RCT protocol and the Clinical part of the Operations Manual.
  • To prepare the clinical package training
  • Distributes optional clinical packages to clinical centres according to their potential/willingness.
  • To follow up recruitment and support to clinical centres to solve barriers to recruitment.
  • Centralise and coordinate request and suggestions from clinical centers for consideration at SC.

WP09 Technology, support and monitoring

  • Provide monitoring of the Randomised Clinical Trial (RCT) to ensure adherence to Good Clinical Practice (GCP).
  • Develop technical support and tools (Central reading, Drug Logistics, Web based ICT)
  • Use of new technologies as Sudoscan (IMPETO), Lifestyle monitoring (THl) and drug compliance (AARDEX), Telemedicine (eDiagnostics)
  • Organisation of training events, materials and support tutorials.
  • Coordination and change control of the Operations Manual.



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