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SERVICES

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Brainstorming

SCIENTIFIC/MEDICAL WRITING

  • Study designs

  • Clinical Protocols

  • 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...)

 PHASE 1 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

QUALITY MANAGEMENT

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  • "Why and how to do CRO oversight?" workshop

  • Sponsor Oversight Plans

  • Audit observation and Corrective And Preventive Action management

  • Standard Operative Procedures creation and writing

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