PHACT’s medical writers are involved at project initiation, working closely with Medical Monitors and Statisticians to develop study protocols, clinical/statistical study reports, and integrated, submission-ready documents according to regulatory guidelines. This allows them to develop an accurate description of your data to ensure that every phase of trial is correctly focused for maximum results. Specific services include:
- Collaborate with project teams to produce concise and comprehensive clinical documents.
- Integrate pertinent information from statistical analyses into clinical study reports.
- Deliver all documentation in electronic formats, according to Sponsor standard operating procedures, report templates, and preferred writing style.
- Provide accurate documents through an intensive internal review and quality control process.
- Prepare electronic submission-ready reports and regulatory documents meeting FDA guidelines.