Documentation Development
The generation of clearly written clinical documentation is critical to clinical trial success. Protocols cannot include all the nuance and detail required to answer all questions and assure consistent implementation of all study procedures across multiple sites, and therefore many studies include the generation of a Study Procedure Manual or other supplementary instructional manual. EndPointe’s can assist in the generation, maintenance, revision and implementation of such documents.
Other document development services include:
- Protocol development
- Investigator brochure generation
- Informed consent form template development
- Study forms
- Pharmacy Manuals
- Monitoring Plans
- Clinical Trial Management Plans
- Annual reports and PSURs
- Standard Operating Procedures
- Training materials (presentations, supplemental materials, etc.)