Making clinical research crystal clear
Quality review services
Poor quality regulatory documents can impact drug development timelines and your company’s reputation. Multiple reviewers, tight timelines, and changing requirements contribute to poor document quality. Document authors are typically responsible for ensuring quality. These authors are usually in high demand, are high cost, and may not have the time, experience, or skill sets required to do a thorough quality review. By using Krystelis’s independent quality review services, you can increase the quality of clinical trial documents while accelerating drug approval timelines and reducing costs.
Our quality review service includes:
- 100% data verification against source documents
- Validation using literature references
- Data integrity and internal consistency checks
- Style and grammar/punctuation checks
- Compliance with template and authoring instructions
- Checking for overall completeness and clarity
We also provide editorial review services including proofreading, editing, and peer-reviewing.