Press Release

CluePoints’ Risk-Based Quality Management (RBQM) Software Wins At Scrip Awards 2019

King of Prussia, PA: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, today announced that it has been awarded best technological development in clinical trials in the 2019 Scrip Awards.

CluePoints’ Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software was recognized for the essential role it plays in improving clinical trials. The solution can help drive the quality, accuracy, and integrity of clinical trial data both during and after study conduct, improving patient safety and increasing productivity, efficiency, and cost-effectiveness.

The Scrip Awards, which are organised by Pharma Intelligence, aim to recognise the crucial role the pharma and biotech industry plays in improving healthcare and boosting global health outcomes. The 15th annual ceremony was held in London on December 4, and the judging was carried out by an independent panel of senior industry experts from around the world.

Award-winning Risk-Based Monitoring

CluePoints’ vision of RBx, where independent data interrogation, comprehensive analysis, and resulting actions become reusable knowledge, has captured the imagination of the industry.

With the evolution of Risk-Based Monitoring and regulatory requirements, combined with sponsor demands for cost-effective solutions that leverage technology and provide improved data quality, real-time Central Statistical Monitoring (CSM) is a “must-have” service.

Commenting on the win, Patrick Hughes, Chief Commercial Officer of CluePoints said,“CluePoints® has been a pioneer in the field of Risk-Based Monitoring over the last 7 years; we continually enhance our Risk-Based Quality Management Solution to ensure that it remains both disruptive and relevant in today’s ever-changing clinical trial space.

“For the industry to acknowledge the value that CluePoints offers to sponsors, CROs and Clinical Technology Partners is an honor. We’re thrilled to be recognized for our proactive innovation, quality management vision and transparent approach, which are central to our success.”

Speaking about the crucial role of technology in the future of clinical trials, a Scrip Awards spokesman said: “This award recognizes the vital importance of using the most sophisticated platforms to catalyze and optimize data gathered during clinical trials.

The Case for Risk-Based Clinical Trials

There are several factors driving the need for RBx, including regulatory changes that have impacted the industry, forcing organizations to re-examine the mechanisms for maximizing clinical trial data quality and how organizations are structuring themselves is changing. In response, CluePoints is committed to helping companies identify, assess, plan, mitigate, monitor and analyze risk across all elements of clinical trial management to comply with regulatory requirements.

“For the CluePoints’ family, staff, customers and stakeholders, this accolade is the icing on the cake, following global expansion and further award wins,” continued Patrick Hughes.

“The new software release demonstrates CluePoints’ ongoing commitment to continuously evolve its platform and add in features requested by its ever-expanding user base. Further, the solution’s continued ability to pinpoint areas of risk isn’t just enabling a more efficient process for Pharma companies and CROs, it is also ensuring better patient safety throughout the study as areas of concern are identified much earlier than previously capable using traditional processes.”

The Future of Clinical Trials

CluePoints 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.

All elements of trial management can be performed using a risk-based approach, aligned with ICH E6 (R2) and other key industry guidelines. By fully embracing a risk-based culture, proactive risk-management supports evidence-based decision making, guards patient safety and ensures the highest quality data.

For further information on CluePoints’ solutions, please visit

Notes to editors:

What are the Scrip Awards?

For 15 years, Pharma Intelligence’s Scrip Awards have sought to celebrate the essential role that the pharmaceutical, biotech and other allied industries play in improving healthcare.

Categories span the entire range of industry activities, from new drug launches and clinical trials, to innovative deals, outsourcing and fundraising.

The Best Technological Development in Clinical Trials Award recognizes the promising and disruptive role that digital health technology now plays in drug development. It applauds advances that focus on helping sponsors create safer, more efficient trials, and that aim to improve the experience of participants.

2019 judging panel:

  • Sir John Bell, Regius Professor of Medicine, Oxford University
  • Laura Brown, Director, LB Training and Development
  • Laurie A. Halloran, President and CEO, Halloran Consulting Group, Inc
  • Brian Hargreaves, Independent Adviser, Private equity consultancy
  • Annalisa Jenkins, CEO, PlaqueTec
  • Trevor M Jones CBE, Chairman, Simbec-Orion Group
  • Viren Mehta, Founder, Mehta Partners
  • Alison Messom, Chairman, Institute of Clinical Research, Director ALM Consultancy
  • Phornvit Phacharintanakul, Chairman, Strategic Business Partners
  • Peter Pitts, President, Center for Medicine in the Public Interest
  • Andy Smith, Director-Analyst, Edison Investment Research
  • Rolf Stahel, Chairman, Chesyl Pharma
  • Robert Spiegel, Founder, Spiegel Consulting
  • Brian Tempest, Chair/Editor, Hale & Tempest Co Ltd/ Journal of Generic Medicines
  • Robert Thong, Independent Consultant and Writer, SciTechStrategy
  • Sir Gregory Winter, Master, Trinity College Cambridge

For more information on the awards click here.

Why do clinical trials need to change?

Since the late 1990s, drug developers have faced growing pressure from all sides. A slowing of innovation, coupled with patent expirations and a continual increase in the complexity of study designs have seen the cost and duration of development timelines rise, and profit margins fall.

Research published by Tufts Center for the Study of Drug Development (CSDD) showed that there had been a dramatic increase in the size and complexity of studies between 2005 to 2015. The report highlights:

  • an 68% rise in the median number of procedures per patient
  • an 88% increase in the overall volume of patient data being collected
  • a doubling in the number of countries participating in each study

Such figures represent a significant uptick in the risk to the operational success of research. They threaten teams’ ability to recruit and retain patients and to generate the reliable results needed to support marketing approvals.

Crucially, they make it more difficult for sponsors and CROs to protect patient safety and the quality of rapidly expanding datasets.

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) is 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 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.

Media Contacts:

CluePoints Contacts:

Patrick Hughes – Chief Commercial Officer, CluePoints

[email protected]

+44 (0) 7703 532 749

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