A protocol has to be scientifically, medically and technically correct, but also be easy for study sites to understand and follow for upkeeping the high quality of the study.
We will help to find the perfect balance and the ideal way to present the information for requirements in your protocol.
Independent document review goals:
- Improve protocol or document technical quality and usability
- Improve site engagement
- Improve patient satisfaction and retention
- Generate quality data (Delivered on time and within budget)
- Decrease protocol deviations
- Shorten time to market for new drug approvals
- Reduce the
amountof amendments, saving time and money
We offer independent reviews of study protocols, ICFs, and other study-related documents and manuals to improve usability for sites and identify issues with content that can delay sites or generate unnecessary amendments.