Medical Writing
We understand the importance of good writing. From protocol to package insert, our goal is to produce concise, substantive, and polished clinical documents.
Our writers have the writing skills, relevant medical/scientific education, and experience to produce expertly-written documents – on time. We strive for clarity, efficiency of presentation, and scientific accuracy. All of our MW deliverables undergo a rigorous copy-editing and QC review to ensure they look good, read well, accurately interpret the study results, and comply with regulatory and stylistic guidelines. Because we are a niche CRO, focusing on oncology only, we can offer an unparalleled level of medical/scientific expertise and oversight.
Prologue’s medical writing team supports preparation of the following:
- Clinical development plans
- Protocols
- Clinical study reports
- Clinical sections and summary sections of Common Technical Documents (CTDs)
- Clinical sections and summary sections of New Drug Applications (NDAs)
- Abstracts, posters, and journal articles
- Investigator brochures and IND annual updates
- Informed consent forms
- Periodic Safety Update reports (PSURs) and other pharmacovigilance documents
- Pre-FDA meeting briefing documents
- Response to clinical hold orders
- Expert reports and executive summaries
- Data Safety Monitoring Board (DSMB) manuals
- Written and tabular summaries
- Medical and scientific literature reviews
- Safety narratives, Investigational New Drug Applications (INDs)
We offer medical writing as part of a full-service program or as a stand-alone service. We have templates and style guides for all of our regulatory submissions – or we can use yours if you prefer.
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