Data Compliance & Submission
Clinical trial data must adhere to global regulatory requirements to be accepted by agencies like the FDA, EMA, MHRA, and PMDA. WEP manages data compliance and submission through a combination of regulatory adherence, data integrity measures, and standardized submission processes.
Global Regulatory Compliance
We comply with all global and local regulatory frameworks, including:
- FDA (U.S.) – 21 CFR Part 11 (electronic records & signatures), CDISC standards (Clinical Data Interchange Standards Consortium)
- EMA (Europe) – Good Clinical Practice (GCP), GDPR for data privacy
- ICH-GCP – International guidelines ensuring ethical and scientific quality
- MHRA (UK) – Compliance with EU and UK-specific clinical trial regulations
- HIPAA (U.S.) – If handling patient health data
How WEP Manages Regulatory Submission
- CDISC Standards (SDTM & ADaM) – Format data to meet regulatory submission requirements
- 21 CFR Part 11 Compliance – Ensure electronic records meet FDA validation standards
- Clinical Study Reports (CSRs) & Statistical Reports – Prepare detailed regulatory documentation
- Regulatory Queries & Responses – Support Sponsors in addressing questions from health authorities
WEP Ensures
- Compliance with regional regulations (e.g., CDISC standards for FDA)
- Correct data formats (eCTD sequence numbers, metadata tagging)
- SAS Data Extractions per FDA submission guidance
- Error-free submission using validation tools (eCTD validators)