We understand the importance of clear medical communications and good writing is critical in the support of a product’s regulatory success. Our goal is to produce concise, substantive, and polished clinical documents that provide clarity and are scientifically accurate from protocol to package insert.
The Clinlogix medical writing team is composed of experienced professionals. Most writers are members of the American Medical Writers Association. Global writing services range from the preparation of individual documents to extensive medical writing programs. Consistent with the Clinlogix therapeutic focus, each medical writer assigned to each project team has the appropriate therapeutic expertise to deliver the highest quality work product.
All writing documents undergo quality review and copy-editing to ensure they accurately interpret the study results, and comply with regulatory and stylistic guidelines.
- Our Medical writing team supports the preparation of the following:
- Clinical development plans
- Clinical study reports
- Clinical sections and summary sections of Common Technical Documents (CTDs)
- Investigational New Drug Applications (INDs)
- New Drug Applications (NDAs)
- Investigational Device Exemptions (IDEs)
- 510K Applications
- Abstracts, posters and journal articles
- Investigator brochures and IND annual updates
- Instructions for Use and IDE annual updates
- Informed consent forms
- Periodic Safety Update reports (PSURs) 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