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Medical Affairs

Overview
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Overview

As a hemato-oncology specialized CRO we put a lot of emphasis on the medical expertise of our people. Consequently our Medical Affairs department comprises of highly trained scientists, doctors and engineers who form the scientific basis of our company and ensure the rigorous training of all HeaDS employees on study Protocols/Disease areas.

To consolidate the scientific integrity of the data and patient safety, our Medical Monitors perform rigorous study specific Medical Review in close collaboration with our Data Management and Clinical Operations teams. Only in this way can we really guarantee a reliable and safe clinical study.

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Services

  • Development and thorough execution of a study specific Medical Review plan
  • Medical assessment of Serious Adverse Events (SAEs)
  • In depth scientific review of all study related procedures (eCRF, Data Management Checks, Statistical Analysis Plan, Clinical Monitoring Plan)
  • Protocol Development
  • ICF Development
  • CSR Development
  • Manuscript Development
  • Authoring of posters and abstracts
  • Laboratory Manuals
  • Development of interactive training courses across a range of diseases in hemato-oncology
  • Development of rigorous assessments to ensure the true understanding of Protocol/Therapeutic area

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