Medical Writing
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Regulatory medical writing

Our expertise covers the preparation of a wide range of documents used in the clinical development of drugs and medical devices, including:

  • Synopses based upon your notes
  • Study protocols according to Good Clinical Practice (GCP) regulations
  • Clinical Investigation Plans (CIP) according to GCP regulations
  • Clinical Study Reports (CSR) (full reports according to ICH guidelines or abbreviated reports e.g. for observational studies)
  • Investigator’s brochures (IB) (including annual updates) according to ICH guidelines
  • Online trial registration and updates at www.clinicaltrial.gov

Our regulatory writing is prepared in accordance with our Standard Operating Procedures (SOPs) or the client’s SOPs with GCP-compliant standards. We may use an aCROnordic or client-specific template. All documents are prepared to the highest standard and include an internal scientific review and quality control with inter-disciplinary team work, involving also research physicians and statisticians in order to ensure the medical and statistical quality of the document.