Parexel Announces Solution for EU Clinical Trials Information System Regulation

Resource hub streamlines and simplifies application process for clinical trials within EU

BOSTON and Durham, N.C. – Sept. 21, 2020 – Parexel, a leading provider of solutions to accelerate the development and delivery of innovative therapies to improve world health, from clinical through commercialization, today announced the launch of a new Regulatory Submissions Hub Service for life science and biopharmaceutical customers in response to the impending implementation of EU Clinical Trial Regulation 536/2014.

EU Clinical Trial Regulation 536/2014 will govern the conduct of interventional clinical trials for every member state in the European Union (EU) and will harmonize the assessment and supervision processes for clinical trials — throughout the EU — in the form of a Clinical Trials Information System (CTIS) set to launch December 2021.The new regulation will require rigid process flows and demanding timelines for clinical trials and Parexel’s Regulatory Submissions Hub Service is designed to support customers in navigating the impact of these complex requirements.

“Parexel has been supporting customers around the world as they prepare for the new Clinical Trial Regulation,” said Paul Bridges, Senior Vice President and Worldwide Head, Regulatory & Access Consulting. “Through this new hub, we now can offer customized solutions to manage every aspect of our customers’ clinical trial submissions. The involvement of one of our key team members in the development of the CTIS platform further demonstrates our unique capability to help customers remain compliant.”

Operating with a Regulatory & Access team of more than 1,000 consultants, including 80 former regulators covering guidances for 110 countries, Parexel’s Regulatory Submissions Hub Service provides customers everything they need to outsource all clinical trials submissions within the EU to a single, dedicated and customized hub.  

To learn more about the CTIS platform, listen to the EMA Clinical Trial Information System webinar today presented by European Medicines Agency (EMA) and DIA with commentary from Rüdiger Pankow, Principal Consultant, Parexel and Clinical Trial Sponsor CTIS, the Product Owner representing the Association of Clinical Research Organizations (ACRO).

About Parexel
Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedInTwitter and Instagram.

 

Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.

 

CONTACT:

Parexel Media Relations

Lori Dorer

+1 978 495 4135

lori.dorer@parexel.com

 

Lindsay LeCain

+1 508 259 9521

parexelpr@w2ogroup.com

 

 

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