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

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