Press Release

CluePoints Experiences Continued Rapid Growth As Demand For RBx Rises

WAYNE, PA – April 09, 2019: CluePoints, a leading provider of Risk-Based Study Execution(RBx) and Data Quality Oversight solutions for clinical trials, has announced a progressive outlook of continued and significant global growth and continued investment in people and technology throughout North America, Europe and Asia Pacific. In response to client need and demand for RBx- a risk-based approach to study execution, CluePoints is:

  • Moving to larger premises in Belgium and the US to accommodate a growing workforce
  • Recruiting operational hires to support customers with implementation planning, on-boarding and technology transfer
  • Investing in product development for continued innovationto fully exploit the potential of advanced data interrogation in clinical research

This latest announcement cements the company’s ambitious growth plans as it continues to drive the paradigm shift towards an entirely different Risk-Based Approach to Study Execution (RBx) from pre-study risk assessment, through risk identification and control to final auditable documentation. It’s a roadmap to help clients identify, assess, plan, mitigate, monitor and analyze risk across all elements of how a clinical trial is managed, closing the loop to comply with regulatory requirements.

CluePoints has already established itself as the leading provider of RBM technology, having experienced tremendous growth in the past years growing from a team of five people in 2012 to currently just over 60, with plans to accommodate 100+ employees by close of 2019. The company was recently crowned a Trends Gazelles Award Winner further reinforcing how exceptional this growth has been, having doubled revenues year on year for the last four years.

“CluePoints’ vision of RBx has captured the imagination of the industry and we intend to broaden the remit to ensure that any element of how a trial is managed can be done with a risk-based approach, according to ICH E6 (R2) guidelines,” commented Francois Torche, CEO at CluePoints. “We are sustaining our investment in future growth and in our long-term vision of CluePoints as THE provider of enabling technologies for ICH E6 R2 compliance, RBx– risk-based study execution, and overall data quality oversight within clinical trials, where data, metrics and actions become reusable knowledge.”

This announcement also follows the appointment of two industry thought-leaders to its senior team: Suzanne Lukac as Senior Account Director and Richard Davies as VP, Solutions Expert. CluePoints’ ethos is to offer expertise in technology, people and processes via its team of subject matter experts while applying a thought-leadership approach to ensure clients’ success.

Our latest whitepaper “Implementing a Scalable Risk-Based Monitoring Strategy” is available to download now.

For further information on CluePoints’ solutions, please visit


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.

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