IDDI (International Drug Development Institute) has recently launched its subsidiary entitled CluePoints, the new software and service provider of Intelligent Statistical Monitoring Solutions. This exciting new development is a follow-up to the IDDI article published last August…and is the latest BioWin Success Story.
Answering to biopharmaceutical sponsors’ search for the optimal approach to targeted monitoring and reduced Source Data Verification (SDV), CluePoints has developed an Intelligent Statistical approach like no other and at the heart of this approach is the SMART™ (Statistical Monitoring Applied to Research Trials) engine. For over a decade, biostatistician Marc Buyse, along with a dedicated consortium of statistical experts and financial support from the Walloon Region, has been actively involved in the SMART™ project**. A software solution, currently patent-pending with the United States Patent and Trademark Office that allows one to assess the quality and integrity of clinical trial data. In relation to the statistical monitoring of clinical trials needed to meet the new recommendations of the regulatory agencies about Risk-Based Monitoring, the project’s aim had been to provide statistical monitoring with an ability to detect the heterogeneity of data throughout investigational centers and to create a “quality label” for clinical trial data. Hence, the launch of CluePoints, in response to the recent industry guidance from the FDA and a reflection paper from the EMA encouraging sponsors to endorse an alternative to traditional on-site monitoring techniques and to explore reduced Source Data Verification (SDV) using a risk-based approach.
CEO of CluePoints, Francois Torche states: “It has taken a considerable amount of time to build the CluePoints solution due to the complex array of statistical algorithms used but the result is a powerful engine that can be used in all late-stage clinical trials. Not only does CluePoints help improve data quality and integrity, it also has the potential to act as the engine to drive millions of dollars in cost savings via reduced monitoring and SDV.”
It’s worth recalling that this SMART™ project, conducted in collaboration with GSK Vaccines, ULB and UCL selected by BioWin, the health cluster of Wallonia, and granted by the regional government of Wallonia following the 7th call for projects. Today, more than 10 years later, the brainchild of Buyse has evolved from this academic research to a full commercial entity. As a matter of fact, Buyse has been cited in the FDA’s Risk Based Monitoring Guidance for his work in detecting fraud in clinical trials using statistical modeling techniques (The Role of Biostatistics in the Prevention, Detection and Treatment of Fraud in Clinical Trials, Statistics in Medicine 18, 1999).
Although, it has taken the IDDI a decade to perfect the statistical algorithms that comprise the SMART™ engine underpinning CluePoints, the pragmatic solution has the ability to drive intelligent on-site monitoring strategies that will result in significant cost and resource savings; and at the same time, improve the quality and integrity of data and reduce regulatory submission risk. The engine is comprised of a comprehensive range of inter-connected statistical tests that make no distributional assumptions about the clinical data but, when aggregated together, highlight difficult to detect issues in the site results. Its technology complements other solutions in the industry that use certain types of Key Risk Indicators (KRIs) in that the SMART™ engine processes all elements of the clinical data in a comprehensive manner with no predetermination of risk.
Driven by the SMART™ engine technology it’s safe to say the exciting launch of CluePoints further confirms Wallonia as a territory of excellence in Clinical Research and will hopefully continue to bring added-value to all biopharmaceutical and Clinical Research Organizations in the region, and successfully respond to environmental concerns linked to the impact of clinical trials.
CluePoints’ solution to risk-based monitoring; indeed a smart approach that has been well-worth waiting for!
* The official inauguration was held on March 27th in the AxisParc of Mont-Saint-Guibert, conveniently located in close proximity to the parent company IDDI. In attendance were: CluePoints’ team and its consultants (13 total), managers from IDDI, potential investors, suppliers, BioWin, UCL and ULB representatives, and several others who contributed to the launch of this hopeful company… already 4 customers in just 5 months!
The new 261m2 office comprises two meeting rooms, an area for the CluePoints analysts, the R&D department working on the Web Portal development (future Software for in-the-cloud Services), an area for BD, finance and QA,…
CluePoints also established its US Headquarters in Cambridge, Mass. in late 2012. This facility will provide support to US clients and partners and is set for continued expansion in the coming months.
A very successful night altogether!
Pictured (l to r): Erik Doffagne, Lead Biostatistician, IDDI; Grégoire de Hemptinne, IT Consultant, Euranova; Bruno Cochard, IT Consultant, Euranova; Pierre-André Marchand, Biostatistician, CluePoints; Vijaya Siddaha, Software Developer, IDDI; Marie-Laure Dyck, Business Development Associate, CluePoints; Patrick Hughes, Chief Commercial Officer, CluePoints; Quentin Dugauthier, IT Consultant, Euranova; Pierre Rion, Chairman of the Board, CluePoints; François Torche, CEO, CluePoints; Marie-Pierre Debroas, VP Finance & HR, IDDI; Léonie Vangasbeke, QA Consultant, CTG.
** The SMART project: a 2-year, €1,3 million project led by a consortium comprising GlaxoSmithKline Vaccines, the Institute of Statistics at Université Catholique de Louvain (UCL), and the Artificial Intelligence Research Laboratory of Université Libre de Bruxelles (ULB).
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