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Clinical Writing Services

Our medical and clinical writing services offer support with accurate documentation across the clinical development process. Delivered by a dedicated medical writing team, we provide accurate, submission-ready documentation compliant with industry standards and requirements.

Our medical writing team has extensive experience in a wide range of clinical therapeutic areas covering phase I through phase IV of global clinical development, including:

Oncology
Gastrointestinal
Renal/Nephrology
Respiratory
Rheumatology

Cardiovascular
Pain
Infectious Diseases
Dermatology
Endocrinology

Our Medical Writing Solutions

The medical writing team work flexibly to your specific requirements, offering a range of bespoke technical writing solutions. From operating procedures, templates and style guides, we can support sponsors with the right documentation to proceed with clinical development.

Our medical and clinical writers offer appropriate guidance throughout your clinical journey, ensuring the process abides to appropriate industry and regulatory requirements.

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Responsive clinical writing

We ensure timely delivery of documents and share our medical writing services closely with key operational departments including Project Management, Biometrics, Medical Affairs, Clinical Operations, Pharmacology, Pharmacovigilance, Regulatory Affairs, and Quality Assurance to produce the highest quality documents.

All documents produced by our medical writing team undergo thorough reviews by the key operational departments and quality checks to ensure the highest standards.

Medical Writing Documents

Our medical writing services cover a range of documents, with full support across the clinical development process. Our medical writing documents and services include:

Study reports

  • ICH GCP compliant Clinical Study Reports (CSRs) Phases I to IV.
  • CSR synopses for public disclosure.
  • Rewriting or amalgamation of existing CSRs and electronic Common Technical Document (eCTD) formatting of CSRs.
  • Development Safety Update Reports (DSURs).
  • Patient Safety Narratives (for CSR inclusion).

Other documents

  • Study protocols, amendments, and administrative changes.
  • Investigator Brochures (IBs).
  • Investigational Medicinal Product Dossiers (IMPDs).
  • Standalone quality checks.

Get medical writing from industry experts

We are always happy to discuss our medical writing services with clients, please do not hesitate to contact us here.

Let’s collaborate

If you think we could be right for you, get in touch.

Submit an RFI/RFP