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February 2014

CluePoints Strengthens and Expands Global Team in Growing Risk-Based Monitoring Market

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2-25-14

Company announces new board and business development appointments

25th February 2014

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has announced three new appointments to its global team. John Colby and Elizabeth Polvent join the company’s U.S business development team, fulfilling a key element in its strategy for growth, while CluePoints also welcomes Jean Stéphenne, President of the Board of Directors of GlaxoSmithKline Biologicals, as a member of its board.

John Colby joins CluePoints as Senior Director of Business Development on the East Coast U.S, providing strategic leadership and driving business growth in the geography. Previously of Aptiv Solutions and PRA International, John brings a strong track record of managing strategic relationships in the clinical trials industry. Elizabeth Povent has been named as the company’s Director of Business Development on the West Coast. Based in California, she has more than 10 years’ Clinical Operations experience in the industry with her most recent roles serving as the key liaison on Federally funded clinical trials, as well as overseeing early-phase clinical development programs. She joins CluePoints to support the growth of the business’ footprint and to establish long-term partnerships with key customers in the region.

In addition to strengthening its business development team, CluePoints has announced that Jean Stéphenne has joined the company’s board of directors. Jean joined SmithKline-RIT (now GSK Biologicals) in 1974 as head of bacterial and viral vaccines production. Through various executive management positions within the company, he has led GSK’s global vaccines business since 1988. From March 2010 to April 2012, he was appointed as the Chairman and President of GSK Biologicals. Jean currently serves as a Special Advisor to the CEO at GSK, is a member of the Corporate Executive Team (GSK Group), as well as President of the Board of Directors of GSK Biologicals.

“CluePoints is at a very exciting time in its development with increasing demand for its solutions as a result of growing regulatory support for practical Risk-Based Monitoring techniques,” comments Jean Stéphenne. He adds, “With a steadily growing global reputation for delivering scientific excellence and innovation, CluePoints is making its mark on the industry and I am delighted to be joining the company’s board and look forward to the opportunity to help build on its achievements.”

Francois Torche, CEO of CluePoints, comments: “I am delighted to announce the three new additions to our global team. In 2014 CluePoints is focused on fulfilling demand in growing markets and achieving new levels of innovation for customers. I believe the insights and experience of each of these new appointments will be invaluable in our ongoing development.”

For further information on CluePoints solutions, please visit www.cluepoints.com

About CluePoints
CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique 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 and EMA, CluePoints® is deployed to support traditional on-site monitoring and can be implemented as the engine to drive a Risk-Based Monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimisation of on-site monitoring and a significant reduction in overall regulatory submission risk.

Media contact
Patrick Hughes
Chief Commercial Officer, CluePoints
Patrick.Hughes@CluePoints.com

EMA Guidance Points to Central Statistical Monitoring

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emea_strap_url_cmyk_rev_en_std_cent.eps MASTER

While capable of conducting high-quality trials, the current oversight process can be expensive and inefficient.

February 1, 2014
By Marc Buyse, ScD
Read the article from ACT

The release of the final version of EMA’s Reflection Paper on Risk-Based Quality Management in Clinical Trials marks an important milestone in efforts to introduce and develop the risk-based monitoring paradigm. As data quality is unquestionably what matters most in determining study success and ensuring patient safety, the latest recommendations have created growing demand for practical solutions to simplify the transition to risk-based techniques and help the industry put regulatory advice into practice.

Current quality systems implemented by sponsors and CROs have been widely acknowledged as time-consuming, while commanding a major proportion of the cost of drug development programs. To minimize the pressure on resources, the EMA reflection paper demonstrates the need for a more systematic, prioritized, risk-based approach to quality management that complements existing quality practices, requirements, and standards. The document draws attention to the fact that the ICH GCP guideline was finalized in 1996 when clinical research was largely paper-based. Since then, the industry, the available technology, and the approach to the conduct of trials, have all evolved considerably necessitating that monitoring approaches follow suit.

Much of the industry would agree that while capable of conducting high quality clinical trials, the current oversight process can be expensive and inefficient. Central statistical monitoring (CSM) could provide the ideal answer as it can help alleviate quality management issues by identifying risk and determining the integrity of clinical data throughout the drug development process. The final version of the EMA reflection paper does not differ much from the draft published two years ago, and essentially endorses the use of CSM. The paper highlights the potential to develop central monitoring systems using statistical methodology to monitor the quality of the trial conduct and data. It supports the use of regular metrics reports to demonstrate that checks are being conducted and ensure compliance with pre-defined monitoring strategies. By doing this, sponsors and CROs will be able to target on-site monitoring visits to address the issues that such visits are better placed to detect.

In light of both the EMA and FDA recommendations, statistical monitoring methods are now proving essential in today’s clinical trials. The use of CSM determines the expected values of each variable by examining the data from all investigative sites involved in a trial to identify statistical outliers. Complex and proven statistical algorithms drill down into individual patient data to detect issues that could put a study at risk and create barriers to successful submissions. The approach is based on the actual clinical data and not subjective indicators. The rationale behind this is that all variables are indicative of quality—whether it is lab data, clinical data, baseline data, or treatment outcomes; everything is analyzed and deemed equally important. In a clinical trial, everything that is collected should be worth collecting, and therefore worth checking. CSM determines the quality and integrity of all data and ensures that monitoring efforts focus on errant sites efficiently.

Looking at the CSM method practically, adopting the approach requires minimal work for study teams in gaining objective information and sponsors who strategically outsource to CROs are also finding increased efficiencies by using the method as an oversight tool to regularly check the quality of their data. Implementing these techniques can not only reduce costs and address the latest regulatory guidance, but can make better use of resources and optimize overall trial success rates.

Marc Buyse, ScD
Founder of CluePoints Inc.
E-Mail: marc.buyse@iddi.com