Press release

Parexel Strengthens Risk-Based Monitoring Offering with New Advanced Statistical Capabilities

Sponsored by Businesswire

a leading provider of Clinical, Consulting and Commercial solutions to
accelerate the development of innovative new therapies to improve the
world’s health, today announced its strategic collaboration with CluePoints,
an industry-leading provider of Risk-Based Study Execution (RBx) and
Data Quality Oversight Software, to enhance overall data quality
oversight and ensure regulatory compliance within clinical trials.
Through the collaboration, Parexel and CluePoints aim 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.

“A proactive risk management strategy to protect patient safety and
ensure high-quality data is at the foundation of every clinical trial we
conduct,” said Gadi Saarony, Executive Vice President and Chief Clinical
Research Services Officer, Parexel. “The addition of the CluePoints’ CSM
solution enables us to look at Risk-Based Monitoring (RBM) differently
and from a holistic point of view so that we can focus monitoring
activities where they are needed, ultimately driving increased
efficiency and productivity while identifying and addressing risks
before problems arise.”

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.

“Our vision of RBx, where independent data interrogation, comprehensive
analysis, and resulting actions become reusable knowledge, is enabling
the industry to progress efficiencies and further improve quality for
sponsors,” commented Patrick Hughes, Chief Commercial Officer at
CluePoints. “CluePoints is looking forward to working closely with
Parexel’s data surveillance experts to identify, assess, plan, mitigate,
monitor and analyze risk across all elements of clinical trial
management, using technology to comply with regulatory requirements.”

For further information on CluePoints’ solutions, please visit
further information on Parexel, please visit

About CluePoints
CluePoints is a premier provider of
Risk-Based Study Execution (RBx) and Data Quality Oversight Software.
Our products utilize comprehensive statistical algorithms to determine
the quality, accuracy, and integrity of clinical trial data both during
and after study conduct. Aligned with guidance from the FDA, EMA, and
ICH E6 (R2), CluePoints® is deployed to support central and on-site
monitoring, medical review, quality risk management and to drive a
holistic Risk-Based strategy in all trials. Coupled with thought
leadership and consulting expertise to aid pre-study risk assessment,
identification of risk controls and solution implementation, you now
have the tools needed to adhere with global regulatory guidance. The
result is increased operational efficiency, lower costs and reduced
regulatory submission risk as part of the industry paradigm shift to RBx.

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 LinkedIn,
and Instagram.

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