HMR has a team of Medical Writers, each with a PhD or degree in life science. Their work is supervised by our Head of Medical Writing, who has many years’ experience of clinical trials.
We offer a complete medical writing service, from protocol synopsis to final report. We write about 10–15 trial protocols and 5–10 clinical study reports (CSRs) each year. We prepare the information and consent form (ICF) and ethics application for all our trials, and CTA applications for about a third. Our template for phase 1 and phase 2 CSRs complies with the ICH Guideline for Structure and Content of Clinical Study Reports (E3), and is designed with early clinical development in mind. We also write papers for publication.
We pride ourselves on the quality of our documents. We achieve high-quality first drafts using sophisticated templates and thorough QC checks, with comprehensive review against the trial protocol; file notes; final tables, figures and listings; and any other relevant information (eg interim reports, SAE reports). That minimises both the review effort by the sponsor and the time taken to finalise documents.
The review process for a CSR includes detailed input from HMR staff, including technical review (usually by the Head of Clinical Science and Medical Writing, or our Chief Medical Adviser), statistical review (to ensure correct interpretation of statistical analyses), and medical review (by the Chief Medical Adviser, a delegated physician, and/or the principal investigator of the trial). A later draft of a CSR, with appendices, is also reviewed by HMR’s Quality department, who include their audit certificate with the final report. Overall, our review process ensures accuracy, completeness, scientific integrity, and clarity, of the final CSR.
We also offer the following.
- Clinical trial protocol
- Investigator’s brochure
- IMP dossier
- Information and consent form (ICF)
- Case Report Form
Application to regulatory bodies
- Clinical Trial Authorisation (CTA) application
- Ethics committee application
- HRA application for trials involving the NHS
- Administration of Radioactive Substances Advisory Committee (ARSAC) application
- Clinical study report (CSR)
- Abbreviated CSR
- Interim report
- Pharmacokinetic report
- Statistical report
Abstract or manuscript for publication
To discuss your medical writing requirements, please contact:
Head of Clinical Science and Medical Writing
020 8961 4130