Press Release

CluePoints Announces Four Year Partnership With ONO Pharmaceutical And Strengthens Risk-Based Monitoring Position In Japan

Successful pilot project prompts strategic partnership that strengthens risk-based monitoring in Japan and places both companies as leaders in their fields.

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has entered into a significant enterprise agreement with leading Japanese drug development organization, ONO Pharmaceutical Co., Ltd.

The agreement sees ONO utilizing the CluePoints centralized statistical monitoring (CSM) platform to drive its RBM strategy over a four-year period and firmly strengthens CluePoints’ established presence in the Asia Pacific market.

Centralized statistical monitoring

Following a successful pilot study in 2017, ONO, who are actively pursuing research and development of drugs for cancer, auto-immune disease, and neurological disease, recognized the impressive cost and resource efficiencies that can be achieved by using advanced statistical methodologies to identify the sites and patients where monitoring is most needed.

CluePoints and ONO will now continue to work in close partnership over the next four years to build on the success of the pilot program.

Experts from CluePoints in Japan will deliver on-site training and provide ongoing support to the ONO team to ensure the adoption of the RBM approach delivers the best possible results.

ICH E6 (R2)

Risk-based monitoring (RBM) is about identifying, assessing, monitoring, and mitigating the risks that could affect the quality or safety of a clinical trial.

It allows trial organisers to move away from 100% source data verification, which can be expensive, time consuming, and unreliable. Instead, they use a detailed risk assessment, to identify the most likely threats to data quality and plan mitigation responses, and continual statistical monitoring, to highlight unexpected issues and select sites for investigation during the study conduct.

The result is more efficient clinical trials that boost levels of participant safety while offering shorter routes to market, increased compliance, and higher chances of overall operational success.

The approach was first outlined by the FDA and the EMA in 2013. The industry has seen an increase in the implementation of a variety of RBM methodologies and technologies since the introduction of the ICH E6 (R2) addendum in 2016.

However, unlike its US and European counterparts, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is yet to release any specific regional guidance on the use of RBM.

The partnership with CluePoints makes ONO one of the first companies in its market to embrace an RBM approach before it has become a regulatory requirement. The move demonstrates the drug developer’s innovative and proactive philosophy, and clearly positions the company as an innovator in the region.


Patrick Hughes, Chief Commercial Officer at CluePoints, comments: “The enterprise agreement with ONO represents a significant step forward for CluePoints, and further cements our position as the ‘go-to’ Risk-Based Monitoring (RBM) provider in the Asia Pacific region.

“It’s an honor for us to work with such a forward-thinking company, who are embracing the global regulatory changes and recognizing the power of RBM before the Japanese PMDA has formally mandated the approach.

“We’re confident that through our continued collaborative approach, our relationship with ONO will prosper, and we are very much looking forward to working with the team over the next four years and beyond.”

CluePoints are pioneers of risk-based study execution (RBx) solutions, offering sponsors and CROs a better way of identifying, visualizing, managing, and documenting risks within trials – risks that could compromise patient safety and delay the approval of investigational products.

The solutions are cloud-based, underpinned by CSM, and can be deployed to support traditional onsite monitoring, remote monitoring, medical review, and quality control.

ONO Pharmaceutical

ONO comments: “We are delighted to announce our partnership with CluePoints, an industry-leading company that supports the practical implementation of RBM techniques in clinical trials.

“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.”

ONO, which grew from an Osaka apothecary founded by Ichibei Fushimiya more than 300 years ago, prides itself on utilising technology and working within strategic partnerships to produce novel drugs that make a different to people’s lives.

The company’s R&D mission is to “contribute to society by developing pharmaceutical products that bring true benefit to patients.” ONO works to develop original, innovative new drugs that target incurable diseases and tackle unmet needs.

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Notes to editors:

What is ICH (E6) R2?

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which provides a unified standard for clinical trials in the European Union, Japan, the United States, Canada, and Switzerland, published the R2 addendum in 2016.

It encouraged the implementation of improved, more efficient approaches to the way clinical trials are designed, conducted, and overseen, as well as recorded and reported. The aim was to take the research industry into the 21st century, while ensuring the highest standards of both participant safety and result reliability.

R2 was a positive step forward for the industry, representing an exciting opportunity for more efficient clinical research and significantly better outcomes. Ultimately, it reflected a desire for studies to be more agile, flexible, and efficient.

What is risk-based monitoring?

Risk-based monitoring (RBM) is the process of identifying, assessing, monitoring, and mitigating the risks that could affect the quality or safety of a clinical trial. The proactive approach allows the study team to move away from 100% source data verification (SDV) – a time- and resource consuming approach that provides far from perfect results – and instead focus resources on high-value tasks.

First written into US and European guidelines back in 2013, RBM received further validation with the publication of the ICH E6 (R2) in 2016.

Many pharmaceutical companies, sponsors, and CROs now follow the TransCelerate RBM methodology. It is a robust risk identification process that allows trial designers to evaluate study risks, and organize them into the following categories:

  • Safety study phase
  • Complexity
  • Subject population
  • Technology
  • Data collection/ CRF source
  • End points
  • Organizational experience
  • Investigational product/ study medication
  • IP logistics / supply chain
  • Blinding
  • Operational complexity
  • Geography

What is centralized statistical monitoring?

Centralized statistical monitoring (CSM) can be described as a data quality insurance policy. It provides a way to identify and respond to less obvious risks, or those that may not have been identified through risk assessment processes.

Data surveillance, through a central statistical assessment of data quality, can flagging anomalies that warrant further investigation.

It works on the assumption that data should be comparable and statistically consistent across centers, other than random fluctuations and natural variations. Unsupervised CSM performs as many statistical tests on trial data as possible to detect inconsistencies that may point to potential problems, without placing additional burden on study teams.

It can spot atypical patterns that represent potential intentional or non-intentional misconduct, such as fraud, sloppiness, training needs, or malfunctioning or mis-calibrated study equipment.

What is risk-based quality management?

Risk-based quality management (RBQM) brings all of these elements together and applies them to the entirety of a clinical trial.

It uses technology, real-time information, and analytics to monitor risk, giving sponsors the ability to identify and correct issues as and when they arise. This enables sponsors and CROs to take corrective action before problems have a chance to impact on the integrity of a clinical trial.

Its fundamental goal is to improve the operational success rate of clinical research through higher quality data, shorter timelines, and greater operational efficiency.

RBQM boosts both participant safety and the likelihood of trial success. As such, it has been backed by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Committee on Harmonization (ICH).

By helping researchers to identify and focus on data that really matter, tech-led RBQM solutions provide the ultimate safety net, both from a patient safety and ultimate success perspective.

The ICH E6 (R2) guideline set out what a gold standard RBQM would cover:

  • Critical process and data identification
  • Risk identification
  • Risk evaluation
  • Risk control
  • Risk communication
  • Risk review
  • Risk reporting

About ONO Pharmaceutical Co. Ltd.

ONO Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. ONO focuses on the oncology, immunology, neurology and specialty research with high medical needs as priority areas toward discovery and development of innovative new drugs.

In keeping with its philosophy of “Dedicated to Man’s Fight against Disease and Pain” ONO Pharmaceutical Co. Ltd. has always strived to achieve its goal of serving as an R&D-oriented global specialty pharmaceuticals, aiming to develop innovative and globally recognized drugs.

For additional information please go to

About CluePoints

CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 15 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the ICH, FDA, and EMA, CluePoints® is deployed to support traditional on-site monitoring, medical review and to drive a Risk-Based Monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.


Media contact

Patrick Hughes – Chief Commercial Officer, CluePoints

[email protected]

+44 (0) 7703 532 749

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