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SERVICES

OVERVIEW

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Brainstorming

SCIENTIFIC/MEDICAL WRITING

  • Scientific and competitive landscapes

  • Study designs

  • Clinical Protocols

  • Clinical Study reports

  • Informed consent forms

  • Subject information leaflets

  • Investigator Brochures

  • Product Instructions for Use

  • Regulatory documents clinical sections

  • Scientific Committees Charters (Advisory boards, Independent data review boards, adjudication committees...)

CLINICAL TRIAL MANAGEMENT

​Scientific

  • Operational teams study training

  • Communication with Key Opinion Leaders

  • Management of Steering Committees and Independent data monitoring committees

  • Protocol Deviation assessment, Data review, Safety monitoring

Operational

  • Lead Project Team

  • Timelines and Budget Planning

  • Study conduct from set-up to closure

  • Bidding and outsourcing

  • Clinical Supplies oversight​

  • Case Report Forms/eCRF designs and data query management

Working with Coffee
Making Notes

CLINICAL MONITORING/ CLINICAL RESEARCH ASSOCIATE

Clinical Sites Monitoring according to International Conference on Harmonisation-Good Clinical Practice (ICH-GCPs):

  • Ethics Committee dossiers

  • Study feasibility and sites selection

  • Site Initiation visits- First Patient First Visits

  • Monitoring, source data verification

  • Database locks

  • Site closures

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