Press Release

CluePoints Opens New APAC Office In Tokyo

King of PrussiaPA – December 8th, 2020: CluePoints, the premier provider of Central Statistical Monitoring, Risk-Based Quality Management and Data Quality Oversight Software for clinical trials, today announced further expansion in Japan with the opening of a new office in Tokyo. Dedicated to serving their Japanese clients, the new office builds on CluePoints’ presence in the region, as demand for modern analytical software and services enabling proactive and exhaustive identification of clinical study quality issues continues to grow. The new location, along with a team located in Osaka, will strengthen CluePoints’ growing reputation within Japan and bring it closer to its Asia-Pacific region customers.

CluePoints has had a series of successes in Japan, conducting numerous studies in the Asia-Pacific region and working with prominent Japanese clients, including a significant enterprise agreement with leading Japanese drug development organization, ONO Pharmaceutical Co., Ltd. CluePoints has also run a hugely popular series of roadshows in the region, helping educate and inform this fast-growing territory. Most recently, CluePoints has worked alongside Japan’s leading CRO, EPS, to produce an on-demand Japanese language webinar on “Using RBQM to drive data quality improvement and improve efficiency through Central Statistical Monitoring of clinical trials.”

Commenting on the new office, Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints said, “This new venture truly signifies our commitment to this region and the company’s wider long-term growth strategy and investment across the Asia-Pacific market. We are supporting global top 20 pharmaceutical studies with cutting edge analytical technology, exhaustively analyzing and improving clinical data quality and contributing to the reduction in the overall risk associated with sponsors’ regulatory submissions. As the appetite for modern risk reduction techniques continues to grow, the new office will provide dedicated operational support and resources to both new and existing clients in the region, opening new partnership possibilities and expansion of existing collaborations. Our team is very excited to be part of this dynamic and innovative development as we establish our base in Tokyo.”

CluePoints continues to drive the paradigm shift from pre-study risk assessment, through risk identification and control to final auditable documentation. Indeed, while the company recorded an average 31% annual increase in organizations using CluePoints’ software over the previous four years, in 2020 this has jumped to an increase of 69%. This momentum offers promising signs that adoption of our risk reduction and quality improving software and services is accelerating, possibly influenced in part by the global pandemic. The industry is realizing the benefits of a modern, informed, risk-based approach applied to all elements of trial management, aligned with ICH E6 (R2) and other key industry guidelines.

John Bolger, Japan General Manager, CluePoints with a long track record of introducing new technologies to the Japanese pharmaceutical market added, “The new office highlights the excellent work that we have done over the past years and that CluePoints is always in search of new possibilities to develop and bring its services to the region. We are committed to helping companies identify, assess, plan, mitigate, monitor and analyze risk across all elements of clinical trial management to comply with regulatory requirements as well as to provide improved outcomes for patients in Japan and beyond. As new guidance continues to evolve, Japanese regulatory authorities are closely aligned with their global partners and have a keen interest in risk-based approaches, recognizing the opportunities it brings to drive better outcomes across the industry. CluePoints is primed to help focus the quality, accuracy, and integrity of clinical trials in this region.”

For further information on CluePoints’ solutions, please visit

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, PMDA 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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