Medical Writing

Medical Writing

Combining clinical development experience with scientific rigour

With strong scientific backgrounds in a wide variety of therapeutic areas, and thorough knowledge of ICH GCP  guidelines, and ISO standards, our Medical Writers are well-equipped to rapidly produce high quality, evidence-backed documents.

Our Medical Writers

The majority of our Medical Writers hold life sciences PhDs from leading Swedish and UK universities, and they have a cumulative 50+ years of clinical development and regulatory experience including:

First-in-human trials, Phase I – IV, post-marketing, Real-World Evidence (RWE), Medical Devices, Advanced Therapy Medicinal Products (ATMPs), and various scientific documents

Of course our other internal expert teams are always on hand as needed (e.g., Biostatisticians, Medical Experts, Medical Device Managers, RWE and Safety) to work in seamless collaboration. The Medical Writing team can support the whole product development life cycle – from scientific advice to protocol development, study reporting to post-marketing support.

Overview of Medical Writing Services

  • Study outline/study synopsis development (in collaboration with internal or external resources such as Biostatistician, Medical Advisor, etc.) 
  • Clinical Study Protocol (CSP)
  • Clinical Study Report (incl. safety narratives) (CSR)
  • Clinical Investigation Plan (CIP)
  • Clinical Investigation Report (CIR)
  • Patient information and Informed Consent Form (ICF)
  • Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
  • Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER)
  • Clinical Performance Study Protocol (CPSP) and Clinical Performance Study Report (CPSR) for an in vitro diagnostic device 
  • Literature review (incl. SOTA literature reviews)
  • Study registration and reporting (e.g., EudraCT, CTIS,
  • Investigator’s Brochure (IB), Investigational Medicinal Product Dossier (IMPD)
  • Scientific advice requests (e.g., to EMA, BfArM, MHRA) including Briefing Book
  • Development Safety Update Report (DSUR) and Periodic Benefit-Risk Evaluation Report (PBRER)
  • Investigational New Drug (IND) Annual Report
  • Manuscripts and other publication support

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