Pharm-Olam International, a global, full-service contract research organization (CRO) specializing in oncology, infectious diseases and vaccines, rare and orphan diseases, provides multiple resources for life science organizations to comply with the new European Union General Data Protection Regulation (GDPR).
Pharm-Olam provides education and consultation on how the GDPR affects clinical trial conduct and also works directly with companies to achieve compliance.
The GDPR, which went into effect May 25, harmonizes data privacy laws across the European Union to protect and empower citizens’ data privacy and reshape how organizations approach data privacy. The regulation upholds subjects’ control of personal data by imposing strict rules on those collecting and processing this data, increasing confidence that the data is appropriately managed. The industry is grappling with implementing the requirements, which could affect companies’ profitability.
To help pharmaceutical and biotechnology companies assess their GDPR compliance readiness, Pharm-Olam provides best practices and resources, such as implementation checklists, training webinars, informed consent form templates and data processing agreements (DPAs). The company advises on all procedures for clinical trial conduct. For companies outside the EU/EEA, Pharm-Olam also provides EU representation for the GDPR.
Organizations can request a webinar led by Natasa Spasic, GDPR-certified data protection officer at Pharm-Olam, that summarizes compliance steps and Pharm-Olam’s Bow Tie Method to manage compliance readiness and assess risks.