Pinnacle 21 is a validation tool used to assess the quality and compliance of clinical trial datasets (SDTM, ADaM, SEND) with CDISC standards. It’s essential for ensuring that data meets regulatory requirements before submission.
The Community version is freely available for individual use, while the Enterprise version is used by regulatory agencies like the FDA. TechyVignan uses the Enterprise version to match agency-level validation, providing greater accuracy and alignment with regulatory expectations.
Pinnacle 21 validates the datasets for errors, warnings, and conformance issues. The FDA uses Pinnacle 21 (DataFit) to review submissions, so resolving issues identified by the same tool enhances the likelihood of smooth regulatory review.
Absolutely. We provide detailed interpretation of validation outputs, classify findings by severity, and offer guidance on how to address each issue effectively to ensure submission readiness.
Yes. Besides the FDA, regulators like the PMDA (Japan) and EMA (Europe) accept and rely on Pinnacle 21 validation results. Our services ensure your datasets are globally compliant, not just U.S.-focused.
