Pharm-Olam Supports Clinical Trials and Sponsors Compliance with GDPR
Pharm-Olam LLC aids Pharmaceutical and Biotechs to understand how GDPR affects clinical trials by providing data protection services and GDPR consulting.
Houston, July 31, 2018 – 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 access 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.
“GDPR is a complex regulation that has a significant impact on the clinical trials industry; sponsor organizations are still seeking support to comply with the new regulation,” said Daniel Burgess, FRQA, chief compliance officer at Pharm-Olam. “By providing manageable plans to implement GDPR, Pharm-Olam helps organizations protect patient privacy, maintain data integrity and mitigate their long-term risk thus avoiding financial penalties.”
To see Pharm-Olam’s services or access free resources to manage GDPR compliance, visit pharm-olam.com.
About Pharm-Olam International
Pharm-Olam International is a global contract research organization (CRO) offering comprehensive clinical research services to the pharmaceutical, biotechnology and medical device industries. From Phase I to Phase IV, Pharm-Olam focuses on delivering the highest quality data, achieving targeted enrollment and meeting projected timelines. Pharm-Olam specializes in the conduct of clinical trials in oncology, infectious disease and vaccines, rare and orphan diseases, as well as continuing to support various other therapeutic areas within general medicine. For further information, visit pharm-olam.com.