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. Working closely with our project teams, Novella’s medical writers ensure accuracy and consistency.
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, but we can also use customer templates and follow customer style guides upon request.
Our medical writing services include:
- Clinical study reports
- FDA briefing documents
- Clinical and summary sections of Common Technical Documents (CTDs)
- Clinical and summary sections of New Drug Applications (NDAs)
- Investigational New Drug Applications (INDs) and Annual Updates
- Investigator’s brochures
- Biologic License Applications (BLAs)
- Informed consent forms
- Abstracts, posters and journal articles
- Executive summaries for efficacy or safety
- Patient narratives
- Package inserts