Effective May 25, 2018, the EU officially adopted the General Data Protection Regulation, better known as GDPR. The sweeping legislation is designed to harmonize data privacy laws across Europe, aimed at protecting and empowering all EU citizens’ data privacy. This has resulted in significant effects in the way clinical research is approached, planned and conducted.
The regulation’s most significant requirements effect or involve:
While Pharm-Olam will not act as a sponsor’s Data Protection Officer, we are poised and ready to provide specific consulting and legal representation services, including:
Pharm-Olam’s turnkey Quality Assurance solution is designed to facilitate diligence and satisfy Sponsor requirements with respect to clinical trial oversight.
The independent position of Pharm- Olam’s Compliance team can deliver diligence and confidence in Patient Safety and Data Integrity throughout the lifecycle of each study.
At the heart of the system is a Risk Management philosophy, using our Bow Tie Method. Pharm-Olam’s risk-based methodology analyzes potential and actual risk scenarios, anticipating and mitigating risks appropriately and proactively. Real-time trend analysis on every level is possible to meet oversight obligations.
For more about our Quality Assurance and Compliance methods, click here.