How Complion helps clinical research sites meet new changes
When the original ICH E6(R1) was released in 1996, clinical trials were performed in a paper environment. Clinical research organizations no longer operate in a purely paper-based world. Sites are now operating in a ‘hybrid environment’ consisting of both paper and electronic processes.
Recognizing that adoption of technology offers “new opportunities to increase efficiency,” ICH E6 guidelines have been revised to reflect two decades of technological changes. Among these changes, include updated standards regarding electronic records and essential documents.
Learn how Complion’s eRegulatory solution helps research sites meet new guidance related to:
- Essential document location tracking
- Document control and ownership
- Certified copies
- ALCOA and Audit Trail standards
- Documentation of oversight
- Additional documents not mentioned in the essential documents list
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