Global Compliance

Premier Research Plays Key Role in Creation of EUCROF GDPR Code of Conduct for Clinical Research Service Providers

MORRISVILLE, N.C., April 16, 2021Premier Research, the clinical research company that’s Built for Biotech℠, is proud to recognize Victoria Watts, Vice President, Privacy and Global Data Protection Officer, for her key role in developing the European CRO Foundation (EUCROF) GDPR Code of Conduct for Clinical Research Service Providers, which was submitted to the Data Protection Authorities of the 27 European Union member states and the European Data Protection Board for approval on March 17. The EUCROF Code is the first consolidated set of data protection rules to address the need for continuous improvement of quality, security, and confidentiality management in the technology-driven domain of clinical research.

“This initiative has been a formidable opportunity to engage high quality and fruitful collaborations with many stakeholders of clinical research, including patient associations, pharmaceutical laboratories, and academic networks,” said Dr. Stefano Marini, Vice President, EUCROF. “The submission for approval is a major milestone and the beginning of a new phase that will result in the establishment of an independent governance body.”

The EUCROF Code was drafted by a dedicated international task force established under the umbrella of the New Technologies Working Group of EUCROF in consultation with EUCROF affiliates and representatives of other stakeholders, including the pharmaceutical industry, patient associations, medical devices companies, and others.

“We are incredibly proud that our own Victoria Watts helped shape policy that will foster transparency and trust in health research,” said Ellen Teplitzky, Premier’s Chief Compliance Officer and Senior Vice President, Legal Affairs.

“This Code is a turning point in the evolution of clinical trial conduct and will inspire greater trust in those companies that adhere to it,” said Ms. Watts. “It was essential that our task force take a very collaborative approach, so all stakeholders had an equal chance to contribute. One of our main goals was to ensure harmonization across all European member states allowing for easier collaborations that, ultimately, will save patient lives.”

About Premier Research

Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.

As a global company, Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.

About EUCROF

EUCROF is a not-for-profit legal entity registered in the Netherlands whose objectives are, among others, to contribute to high-quality Clinical Research in humans and to promote the excellence of European Clinical Research to the public and the media, as well as on the international stage.

The members of EUCROF are national CRO associations as well as individual CROs established in one or more European countries or outside Europe, as defined in its Bylaws. Today EUCROF has more than 380 affiliated companies in 25 countries. The list of EUCROF members, as well as EUCROF Bylaws, are public and can be freely downloaded from EUCROF’s website (www.eucrof.eu).

Day-to-day management and representation of the Federation is performed by an Executive Board (EB) consisting in a group of elected executives (President, Vice-President, Secretary, Treasurer, Executive Board member). Executive Board mandates are for two years.

EUCROF’s financial resources come (a) first from the regular annual fees paid by its members, (b) ad hoc complementary budget lines contributed by its members and affiliates on a voluntary basis, to subsidize strategic initiatives, and (c) income from the training and educational programs and events sponsored and organized by EUCROF.

EUCROF develops its activities through working groups consisting in subject-matter experts selected among the affiliated CROs and contributing on a voluntary basis.