Case study 2
CASE STUDY 2 :
Mid-size eClinical Company, USA
Problem Statement
- Faced challenges ensuring compliance with global regulations including GDPR, HIPAA, 21 CFR Part 11
- Required a robust DPIA process to ensure data integrity and privacy.
- Needed comprehensive CSV for their suite of eClinical products, including EDC, ePRO/eCOA
Our Approach
- Comprehensive CSV Program: Developed and executed validation protocols for EDC, ePRO, and CTMS.
- Regulatory Compliance Assessments: Conducted GDPR, HIPAA, and 21 CFR Part 11 assessments to identify gaps. Mitigation and corrective measures.
- DPIA Implementation: Designed and executed DPIA frameworks to evaluate and mitigate privacy risks.
- Stakeholder Collaboration: Engaged with cross-functional teams to integrate compliance into product development lifecycles.
Success Story
- Achieved full compliance with GDPR, HIPAA, and 21 CFR Part 11 standards.
- Ensured robust data integrity and privacy across all eClinical products.