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
- Formatting
- 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.


Benefits of independent quality review services delivered by Krystelis
Extensive experience in providing quality review services
Dedicated quality review team
Review is fully independent of document authors
Quick project start-up and an expedited approach for urgent requests
Standardised process supported by robust checklists
Approach optimised for each customer and document type
Scalable engagements, from a single document to an entire submission
We can work directly with your internal authors or vendors
Faster regulatory approvals
