Parexel pens CluePoints collab for risk-based monitoring work

Parexel building
Paraxel recently beefed up its regulatory team with the addition of a series of former FDA staffers earlier this year. (Parexel)

Parexel is looking to bolster its clinical trial work and compliance by signing a new deal with CluePoints.

The firm, which describes itself as a provider of risk-based study execution and data quality oversight software, will work with Parexel using its central statistical monitoring (CSM) tech designed to “enhance data quality and reduce operational costs.”

Parexel and CluePoints say in a statement that the point of the deal, financial details of which are not being shared, is to “drive the quality, accuracy, and integrity of clinical trial data both during and after study conduct as well as increase productivity, efficiency and cost-effectiveness for sponsors.”

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Parexel said: “With the adoption of ICH E6 (R2), establishing new requirements to facilitate the mutual acceptance of clinical data by regulatory authorities, there is a greater need to generate higher-quality data in a timely and cost-efficient manner.

“The addition of CluePoints’ CSM technology to facilitate the early identification of anomalous data, optimize on-site and central monitoring and reduce overall regulatory submission risk, coupled with Parexel’s extensive industry experience and RBM expertise, will help to meet the evolving needs of the industry and deliver safe and effective treatments to patients.”

Boston-based Parexel went private back in 2017 with a $5 billion Pamplona Capital buyout deal. Not long after, Josef von Rickenbach, its former chair and CEO, retired from his daily duties at the CRO after a 35-year tenure, passing the baton to Jamie Macdonald, who was previously the helmsman of rival CRO INC Research.

It recently beefed up its regulatory team with the addition of a series of former FDA staffers earlier this year.

The four were: Kurt Brorson, Ph.D., coming off a 26-year stint within the FDA, primarily in the Center for Drug Evaluation and Research; Changting Haudenschild, M.D., who spent 12 years at the Office of Tissue and Advanced Therapies at the Center for Biologics Evaluation and Research (CBER); Mohammad "Mo" Heidaran, Ph.D., a nine-year vet at the CBER; and Mwango Kashoki, M.D., who spent 16 years at the FDA on drug review, development and regulatory work.

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