HMR has a team of dedicated 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) per year, and we prepare the information and consent form (ICF) for all trials for which we’re the primary study site. Our CSR and protocol templates comply with the relevant ICH Guidelines and are designed with early clinical development in mind. We also write papers for publication.
We pride ourselves on the high standard of our documents. We deliver high-quality first drafts that minimise the review effort required of the sponsor and shorten timelines. We achieve that by using sophisticated templates that incorporate decades of HMR experience, in combination with thorough quality control procedures.
Our protocols and CSRs undergo comprehensive technical review by a senior clinical scientist or Medical Writer, with input from relevant HMR staff, including (as applicable): the principal investigator of the trial (or a delegated physician), the HMR statistics department, ward teams, laboratory and pharmacy staff, and our Chief Medical Adviser. A later draft of the protocol or CSR (with appendices) is audited by HMR’s Quality department. Overall, our internal review process ensures the accuracy, completeness, scientific integrity, and clarity of the final document.
As a corporate member of the Plain English Campaign, HMR is committed to using clear and concise language across all documents that we write.
Please contact us to discuss your medical writing needs, whether as part of a full-study service at HMR or not – we’re here to help!