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The services we provide in the field of Clinical Research are:

Clinical Trials Management

  • Study planning & set up
    - Feasibility
    - Site screening & selection
    - Organization & conduct of Investigator's meetings
    - Planning, budgeting & resourcing
    - Trial files construction
    - Submissions to IRBs & regulatory authorities
    - Trial initiation

  • Study conduct
    - Study monitoring
    - Project management
    - Assistance in Safety reporting
    - Essential documents maintenance
    - Continuous communication with investigators, regulatory authorities & IRBs

  • Study close out
    - Site closing
    - Trial files finalization & archiving
    - IRB & regulatory authorities reporting

Functional Outsourcing

In cases where clinical studies will be conducted at the site of the sponsor, the Functional Outsourcing Department ensures that all appropriate administrative and clinical research personnel resources are available for outsourcing to the respective clients’ departments.

Medical Affairs

  • Concept development & evaluation
  • Protocol writing, editing and review
  • Patient documents development
  • Case Report Form design
  • Study Manual development
  • Safety review
  • Medical support & advise during study conduct
  • Translation of medical documents
  • Clinical study report preparation
  • Medical writing

 

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