Clinical Research and Regulatory Writing

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Clinical Research and Regulatory Writing

Pre-Study Documents

  • Clinical Trial Protocols
  • Investigator’s Brochure (IB)
  • Clinical Study Report (CSR)
  • Clinical Evaluation Report (CER)
  • Case Record Form (CRF)
  • Informed Consent Form (ICF)
  • Patient Information Sheet (PIS)

Post Study Documents

  • CTD Modules 2.5 Clinical Overview
  • CTD Modules 2.7 Clinical Summaries (ISS/ISE)
  • CTD Modules 5.2 Tabular listings of Clinical Studies
  • CTD Modules Non Clinical Sections (2.4, 2.6 and 4.0)
  • Responding to Health Authority Queries
  • Patient Safety Narratives

Product Label

  • Label Preparation and updates (CDS, USPI, SmPC and LPDs)
  • Label QC
  • Package Inserts (PI)
  • Structured Product Labelling (SPL)