RBM provider CluePoints inks 4-year partnership with Japanese firm

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/ChakisAtelier)
(Image: Getty/ChakisAtelier)

Related tags: Risk-based monitoring, RBM, CluePoints, Software, GCP, Good clinical practice, Data integrity, Data management, Data

Japan-based ONO Pharmaceutical will use CluePoints’ centralized statistical monitoring platform to lead its RBM strategy over the next four years following a successful pilot study in 2017.

CluePoints provides risk-based monitoring (RBM) and data quality oversight solutions for clinical trials.

The company today announced that it has entered into an enterprise agreement with the Japanese drug development organization, ONO Pharmaceutical Co., Ltd., which is pursuing research and development of drugs for cancer, autoimmune and neurological disease

Patrick Hughes, chief commercial officer, CluePoints, told us the partnership represents a “landmark event”​ for CluePoints and ONO.

“CluePoints have been working with ONO for some time but this consolidates the position with such a valuable customer and strengthens CluePoints position as the ‘go to’ provider of risk-based monitoring software in the AsiaPac region,”​ Hughes said.

“For ONO this demonstrates that they are willing to get out in front of the regulations and Japan and show industry leadership in the adoption of a new game-changing technology to make their trials much more efficient,”​ he added.

CluePoints experts in Japan will provide on-site training and ongoing support to the ONO team.

Good clinical practice

The ICH E6 (R2) addendum outlines​ approaches to clinical trial design, conduct, oversight, recording, and reporting. Following its introduction in 2016, the industry has increased implementation of RBM methods and technologies.

Read more: How to prepare for ICH E6 R2 implementation

However, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has not released any specific regional guidance on the use of ICH E6 (R2), according to CluePoints.

ONO in a press release commented: “It is vital that technology and software developers and pharmaceutical companies work together to ensure new technologies meet the needs of today's trials.

Integrating CluePoints software into our trials will enable us to achieve positive results in terms of significant cost and efficiency savings as well as giving us peace of mind that the data is accurate and conforms to industry regulations."

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