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For each study, we build a dedicated team:

  • Central coordination: a Project Manager, Access Gate for the sponsor, assisted by a Study Assistant
  • Countries:
    • CRAs: Pre study visit, Site selection, Investigator Training, Site Initiation Visits, Interim Monitoring visits, Site Management, Site Support, Close out visits
    • Study Technicians, Study nurses: Support to the centre and investigators

Special Focus on the study critical phases: dedicated tools, specific processes





  • Identification and Selection of the best recruiters investigators
    • Fast and reliable Feasibility studies
      • Strong track record
      • Network of investigators
      • Country targeting: relevant allocation of the sites according to the study specificities (Western Europe, Central and Eastern Europe, Emerging countries)
      • Web 2.0 Feasibility questionnaires
  • Shortening of the initiation phase
    • Medical writing
    • Submissions (EC, MOH)
    • Negotiation of financial agreements
    • Initiation visits
  • Support to the centres to facilitate patient recruitment and improve patient retention
    • Support to the centres by study technicians or nurses
    • Patient Supply Chain
    • Planning of the visits
    • Direct contacts with patients, according to regulations

Transparency with the sponsor

  • Definition of a clear communication plan
  • Key Performance Indicators (KPI)
  • Periodic status reports
  • Study Dedicated Website
  • Periodic Lesson-Learned Meetings with the sponsor

Services:

  • Phase I (Monitoring)
  • International Phase II/III
  • Rescue studies
  • Local and international late phases
  • Post Marketing surveys
  • Registries
  • Project Management
  • Monitoring
  • Audit / Quality Control
  • Regulatory Submissions
  • Coordination of printing
  • Coordination of Study drugs logistics
  • Coordination of third part vendors
    • Central Laboratory
    • Central Imagery Interpretation
    • Local CROs
  • Payment of investigator fees