Medical Writing

CNS understands the importance of bringing experts together in designing clinical trials. We have taken this a step further by resourcing our broad medical writing team within our BioDesk division.

BioDesk's medical, toxicology, CMC and regulatory experts work closely with the senior clinical operations team in the development of the following core documents:

  • Preclinical Program Gap Analysis
  • Drug Development Plan (DDP)
    DDPs are designed in close partnership with our clients and are global in scope, meeting the international standards of the EMA, FDA, ICH and the World Health Organisation (WHO)
  • Protocol Development
    Full protocols are written with input from CNS' medical, biostatistic & clinical experts ensuring practicality, compliance and quality
  • Investigator Brochure (IB)
    IBs are written with input from CNS’ medical, toxicology and CMC experts and in accordance with quality practices
  • Independent Toxicology Report (ITR)
    ITRs are generated by our toxicology experts
  • ECTD ready Clinical Study Report (CSR)
    CSRs are written with input from CNS’ clinical and quality assurance experts and the Local Medical Monitor, in accordance with protocol requirements and ICH E3 standards