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LOUVAIN-LA-NEUVE, BELGIUM; KING OF PRUSSIA, PA; and LONDON, UK (September 1, 2020) – CluePoints S.A., a provider of Risk-Based Study Execution (RBx) and Data Quality Oversight software for clinical trials, today announced a minority investment from Summit Partners, a global growth equity investor with $21 billion in assets under management. Summit will support the company’s continued growth and global expansion to meet accelerating customer demand worldwide.

CluePoints is a pioneer and established leader in Risk-Based Quality Management (“RBQM”), offering solutions designed to provide pharmaceutical companies and CROs a better way of identifying, visualizing, managing and documenting risks that may impact the outcome of clinical trials. Using patented statistical models to determine the quality, accuracy and integrity of clinical trial data, CluePoints’ cloud-based solutions helps sponsors to remotely monitor clinical and operational data in real-time to increase efficiency, improve patient safety and reduce costs. Since the company’s founding in 2012, CluePoints’ solutions have been used in over 600 clinical trials by many of the top pharmaceutical companies and CROs around the world. 

“CluePoints has seen strong growth in recent years as sponsors and CROs across the pharmaceutical industry are embracing RBQM solutions to enable a safer, more efficient and more reliable form of monitoring clinical risk – a market need that has been further accelerated by the COVID-19 crisis,” said François Torche, co-founder and CEO of CluePoints. “Summit has an impressive history of partnering with founders of growth companies and has helped scale many global healthcare, life sciences and software businesses. We believe this experience, in combination with Summit’s deep operational resources, will help CluePoints build on our significant momentum as we continue to expand our international presence and drive product innovation to improve the clinical trial process worldwide.”

Patrick Hughes, co-founder and Chief Commercial Officer of CluePoints, added, “Summit shares our view that RBQM can be a catalyst for long-overdue change in the clinical technology sector. We believe the industry is at an inflexion point and expect to see continued, rapid adoption of these solutions. Together, Summit and CluePoints will work together to invest in both products and people with a vision to build on the company’s market leadership position. We are excited about the opportunity this collaboration offers the customers and partners of CluePoints.”

As industry regulators, including the FDA and EMA, have pushed the pharmaceutical industry to adopt RBQM strategies to more effectively monitor clinical trial risk, CluePoints has firmly established itself as a market leader in this rapidly evolving sector. The company’s solutions are designed to address these requirements to ensure regulatory compliance and to de-risk regulatory submissions. CluePoints’ cloud-based products are deployed to support or replace traditional onsite monitoring to drive a Risk-Based Approach to Study Execution (RBx) and ultimately to achieve ICH E6 (R2) compliance.

“We believe CluePoints offers one of the most intuitive, scalable and statistically powerful RBQM solutions available globally to sponsors and CROs,” said Thomas Tarnowski, a Managing Director at Summit Partners, who has joined the CluePoints Board of Directors.“CluePoints’ software seeks to address what we see as a critical need for risk-reduction, improved patient safety and quality oversight solutions across the pharmaceutical industry. We are thrilled to partner with co-founders François Torche and Patrick Hughes and the entire CluePoints team in this next phase of growth.” 

About CluePoints

CluePoints is the 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 everything you need 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. For more information, please visit www.cluepoints.com.

About Summit Partners

Founded in 1984, Summit Partners is a global alternative investment firm that is currently managing more than $21 billion in capital dedicated to growth equity, fixed income and public equity opportunities. Summit invests across growth sectors of the economy and has invested in more than 500 companies in healthcare, technology and other growth industries. Summit maintains offices in North America and Europe and invests in companies around the world. For more information, please see www.summitpartners.com or follow on LinkedIn. 

In the United States of America, Summit Partners operates as an SEC-registered investment advisor. In the United Kingdom, this document is issued by Summit Partners LLP, a firm authorized and regulated by the Financial Conduct Authority. Summit Partners LLP is a limited liability partnership registered in England and Wales with registered number OC388179 and its registered office is at 11-12 Hanover Square, London, W1S 1JJ, UK. This document is intended solely to provide information regarding Summit Partners’ potential financing capabilities for prospective portfolio companies.