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DATA PROTECTION SERVICES

PHARM-OLAM OFFERS A VARIETY OF DATA PROTECTION CONSULTING SERVICES THAT CAN HELP YOUR ORGANIZATION STAY ON THE CUTTING-EDGE OF DATA PROTECTION REGULATIONS AND LEGISLATION.
From Our Quality Assurance & Compliance Team

DATA PROTECTION EXPERTISE & CONSULTING

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:

 
  • Data Subject Rights
    • Prior Consent
    • Transparent plain language
    • Breach Notification
    • Right to Access
    • Right of Correction
    • Right of Restriction
    • Right to Object
    • Right to be Forgotten
    • Data Portability
  • Privacy by Study Design
  • Data Protection Impact Assessments
  • Data Protection Officer (DPO) Requirements
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Independent Oversight & Consulting on Data Protection Processes for Sponsors

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:

  1. Serving as the EU Representative for the GDPR non-EU based companies
  2. GDPR compliance assessment and implementation plan development
  3. Documentation, policy and procedure development and management including: Subject Rights, Breach Reporting, Data Protection Impact Assessments (DPIAs), etc.
  4. Regular staff training and on-site assistance, including updating Senior Management on GDPR compliance status
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Managing Risk Through Our Bow Tie Method

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.

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