Standards & Compliance

Regulatory Compliance

TEMPO can be deployed as part of a validated system that complies with GCP predicate rule requirements, laws, and regulations for clinical trial conduct and FDA 21 CFR 11 for electronic record and signature use.

CDISC Support

Clinipace is committed to supporting industry standards such as the Clinical Data Interchange Standards Consortium's (CDISC) Study Data Tabulation Model (SDTM). Our clients benefit from having the ability to import and export CDISC files, as well as reduce the time and resource requirements to build a CDISC SDTM-compliant study.