Market Overview

Pharm-Olam International Supports Clinical Trials and Sponsors Compliance with GDPR


, 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'

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

Organizations can access a webinar
led by Natasa
, 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
, 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

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,

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