ACRO to focus on regulatory changes in 2018 with Covance CEO Ratliff as new chair

The 2017 HR in Hospitality Conference placed a heavy focus on “Innovation and Technology," leading to an evolution of the position across the industry.
Implementations of the Cures Act in the U.S. and the upcoming General Data Protection Regulation in the EU are ACRO's top priorities in 2018. (Pixabay)

Covance CEO John Ratliff has been elected as the Association of Clinical Research Organizations’ 2018 chairman, as ensuring smooth implementation of regulatory changes in the U.S. and Europe remains the industry group’s top priority.

Ratliff has been Covance’s CEO since September 2016, and he had also previously spent about 10 years at Quintiles (now IQVIA) before leaving as the CRO’s president and COO for the top job at Huya Bioscience International. He was ACRO's vice chairman when former Bioclinica CEO John Hubbard exited as the 2017 chairman, and his tenure will last for one year.

“I am very pleased to have the opportunity to serve as chair of ACRO during a period of dynamic change and enormous innovation within our industry,” said Ratliff in a statement. “As the collective voice of innovative research organizations, I look forward to ACRO’s continuing collaboration with regulators and policymakers around the world.”

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Helping members with regulatory adoptions will still be ACRO’s top priority heading into 2018, said Douglas Peddicord, Ph.D., ACRO’s executive director.

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In Europe, the focus is on preparing for the May 25-effective General Data Protection Regulation, which is designed to harmonize data privacy laws across EU countries. Peddicord told FiereCRO that ACRO is talking to regulators and customers about new rules relevant to biomedical research. In the U.S., ACRO aims to further incorporate real-world evidence and innovative trial designs into clinical research.

“ACRO was very pleased by the immediate implementation of provisions in [the 21st Century Cures Act] to support the use of single IRBs for multicenter trials, needed improvements to, and encouragement of data sharing across research organizations,” said Peddicord. On that front, ACRO is providing input to the FDA on developing related guidance.

The organization is also working with nonprofit TransCelerate through the CRO Forum commenced in 2015. TransCelerate is working on more than a dozen industrywide initiatives aimed at improving the practices of clinical research. With their on-the-ground experience and expertise, ACRO members help inform some of TransCelerate’s projects, such as risk-based monitoring, quality management systems, eSource and the shared investigator platform.

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In 2017, ACRO also worked to get CROs a portion of the R&D tax credit. Although that part was not included in the final GOP tax bill signed into law by President Donald Trump, Peddicord said ACRO members welcome the reduction in corporate tax rates.

Other members elected to this term of the ACRO office include Cynthia Verst, IQVIA’s president of clinical operations, as vice chairman, Covance’s Brian Nutt as Treasurer and IQVIA’s James Erlinger as secretary.