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

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