Standards Consulting
Pinnacle 21 offers a unique blend of experience and practical knowledge that is applicable across the clinical data lifecycle. We not only understand the standards; we understand how health authorities employ them within review processes. Our standards-driven services provide guidance and support from protocol to submission.
- SME consulting services for SDTM and ADaM
- Client Standards Governance for Standards, Controlled Terminology, and eSubmission Documentation
- Managing FDA data standardization plan
- Clinical data compliance evaluation utilizing P21 tools and SME reviews
- Standards road map from data collection through submission
- Clinical data e-submission process training