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Regulatory & Clinical Writing



  • Clinical Study Protocols
  • Clinical Study Reports (CSR)
  • Informed Consent Forms
  • Patient Narratives
  • Investigator Brochures
  • CTD Module 2 Summaries for Food and Drug Administration (FDA) and European Medicines Agency(EMA) submissions
  • Integrated Summaries of Safety (ISS)
  • Integrated Summaries of Efficacy (ISE)
  • Experienced working on components of New Drug Appplications (NDA),Investigational New Drugs (IND), Biologics License Applications (BLA) and Marketing Authorisation Application (MAA)




  • Clinical Investigational Plans
  • Clinical Investigational Reports
  • Clinical Evaluation Reports
  • Lay Summaries



  • Scientific peer review
  • Editing
  • Peer Review
  • Formatting


  • Preparation of Standard Operating Procedures (SOP)
  • Work Instructions & Guidelines
  • Training & Mentoring


  • Writing for Human Medicine and Veterinary Medicine





I have had the pleasure to work with Rebecca for over 10 years while she was leading the Medical Writing Department at a Clinical Research Organisation. Rebecca understands the meaning and importance of timelines to her clients. At critical times, she is able to integrate herself within a sponsor team where her combined medical writing expertise and clinical research experience are valued. Rebecca is professional and proactive with high expectations of her work and leads by example.

Senior Management, CRO

Tel: +44 (0) 7985 417069 or (0) 7480 497573