• Study Protocol / Clinical Investigation Plan
  • Case Report Forms (CRFs)
  • Informed Consent Forms / Ascent Forms
  • Investigator’s Brochure (IB) IMPD
  • eCTD Modules 2.5 and 2.7
  • Preclinical study reports
  • Safety Narratives
  • Clinical Study Reports (CSR)
  • Clincal Evaluation Reports (CER)
  • Abbreviated Clinical Study Reports / Synopsis
  • Publication Manuscripts and Posters
  • Protocol Slide Kits
  • Investigator Training Material
  • Site Source Documents Development – patient diaries, source document template etc.
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