Novella Clinical understands the importance of medical writing — from protocol to package insert — and our goal is to produce concise, substantive and polished clinical documents.
Our medical writers have the skills and relevant medical/scientific education to produce expertly written documents, and they are integrated with our project teams to ensure accuracy and consistency.
Our expertise includes indication for use statements, product label claims, interim analysis and periodic safety reports, annual IDE updates, clinical evaluation reports, and final CSR compilations for both sponsors and regulatory agencies. Additionally, for post-market support, we offer writing for medical journals, abstracts, registry protocols and CSRs.
Using a flexible approach, we offer medical writing as a component of a full-service program or as a stand-alone service. We maintain a library of ICH templates for regulatory submissions, and we can also use customer templates and follow customer style guides upon request.
Our Medical Writing Services Include:
- Abstracts, posters and journal articles
- Biologic License Applications (BLAs)
- Clinical and summary sections of Common Technical Documents (CTDs)
- Clinical and summary sections of New Drug Applications (NDAs) and Premarket Approvals (PMAs), 510(k), etc.
- Clinical evaluation reports (CER)
- Clinical study protocols and reports
- Executive summaries for efficacy or safety
- FDA briefing documents
- Informed consent forms
- Instructions for use (IFU)
- Investigational New Drug Applications (INDs) and annual updates
- Investigator’s brochures
- Package inserts
- Patient narratives