Are Your Outsourced R&D Partners Ready for 2018?
The latest news from Outsourcing-pharma.com investigates the compliance challenges being faced by companies, their information technology teams, and their outsourced R&D partners in light of the upcoming EU General Data Protection Regulation (GDPR).
The GDPR, which will go into effect on May 25, 2018, has been called “the most important change to data privacy regulation in 20 years,” and will impact most companies that handle personal data of EU citizens.
Although the regulation applies to many contract research organizations (CROs) and their clients, only 8 out of 40 top CROs have achieved EU-U.S. Privacy Shield Framework certification, which demonstrates adherence to GDPR requirements.
Outsourcing Pharma interviewed Elizabeth Iorns, Ph.D., CEO and Co-Founder of Science Exchange, which received Privacy Shield Framework certification earlier this year. Dozens of companies are partnering with Science Exchange to mitigate risk — knowing that, by outsourcing R&D through Science Exchange’s secure platform, they will be protected from fines and noncompliance, even if CROs are not compliant.
Andrew Gutierrez, CFCM, Science Exchange’s Director of Contracts and Compliance, adds his thoughts around the implications of GDPR on pharma, biotech and life sciences: “With the GDPR compliance deadline imminent next year, companies based in the US and operating in the EU must have a strategy in place to ensure they’re prepared for the impact on data transfer processes, including with their outsourced R&D partners.”
“With the right plan in place, organizations can adhere to regulations and remain competitive, without disruptions to R&D programs. At Science Exchange, we reviewed our processes and quickly received EU-U.S. Privacy Shield Framework certification. These steps not only protect our customers and the outsourced R&D data transferred through our platform, but also save our customers significant time and resources they might spend ensuring compliance — or paying up to 20 million euros in fines for noncompliance.”
Be safe and GDPR-compliant – contact Science Exchange to request a demonstration of our platform and a free consultation with our compliance team.