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Implementing a Risk-Based Quality Management Strategy – The Ultimate Guide

Every organization faces unique challenges when it comes to implementing a Risk-Based Quality Management strategy. There’s no ‘one-size-fits-all’ approach that will ensure success, as each organization has specific influencing factors such as therapeutic areas, existing processes, and various technologies. Our latest guide, produced by our Chief Scientific Officer, Steve Young, takes a look at considerations for ensuring not only a successful rollout but its scalability across the enterprise and:

  • The importance of Risk-Based Monitoring/ Risk-Based Quality Management.
  • Best practices based on lessons learned from actual Risk-Based Quality Management initiatives.
  • How to establish your business objectives.
  • Defining your RBQM approach.
  • Managing the change.
Download the Guide

ABOUT STEVE YOUNG

As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers on RBQM methodology and best practices. Steve worked for three biopharmaceutical companies over a span of 15 years where he assumed leadership positions in clinical data management and led the successful enterprise roll-out of EDC at both J&J and Centocor. He spent an additional 6 years with eClinical solution providers Medidata and OmniComm, leading the development of analytics and risk-based quality management (RBQM) solutions and providing RBQM consultation to many organizations. Steve also led a pivotal RBM-related analysis in collaboration with TransCelerate, and is currently leading RBQM best-practice initiatives for several industry RBM consortiums. Steve holds a Master’s degree in Mathematics from Villanova University.

ABOUT CLUEPOINTS

CluePoints offers Sponsors and CROs a better way of identifying, visualizing, managing, and documenting trial risks that could compromise patient safety and delay the approval of Investigational Products. Underpinned by Central Statistical Monitoring, a technique that’s currently being investigated by the Food and Drug Administration (FDA) for selecting sites for inspection, our cloud-based Risk-Based Quality Management software is deployed to support traditional onsite monitoring, medical review and quality to drive a Risk-Based Approach to Study Execution (RBx) and ultimately, to achieve ICH E6 (R2) compliance.

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

King of Prussia, PA – December 5, 2019: 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.

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.”

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.”

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 www.cluepoints.com

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.

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Media Contacts:

CluePoints Contacts:

Patrick Hughes – Chief Commercial Officer, CluePoints

Patrick.Hughes@CluePoints.com

+44 (0) 7703 532 749

As Demand for RBx Soars CluePoints Continues Global Expansion Alongside Further Award Wins

KING OF PRUSSIA, PA – October 22, 2019: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced major expansion as it bolsters its offering with two new larger offices to accommodate its growing family of employees and contractors. This coincides with another distinction which saw CluePoints scoop Scale up of the Year (Most Promising Company of the Year) at the recent 2019 EY Belgium awards. The move to larger premises located in King of Prussia, US and Louvain-la-Neuve, Belgium, creates an extra 3,111 square feet to accommodate growth and an increase in employee numbers.

Demand for CluePoints’ software and services has fueled a fresh wave of expansion in the US and Belgium. Commenting on the growth and EY Belgium accolade,Patrick Hughes, Chief Commercial Officer of CluePoints said, “We’re not resting on our laurels. The move to bigger premises is a testament to our exponential success as a company and our continued investment both in the product suite and our valued client partners. We have increased our employee base as we needed to scale-up to accommodate the increased demand for our services and also to facilitate the significant growth we have slated for 2020 and beyond. We have a clear roadmap for the business, and we are all looking forward to the months ahead.We’re delighted to be recognised for our continued innovation, transparency and quality which are the keys to our success”

The company’s vision of RBx, where data, metrics and actions become reusable knowledge,has captured the imagination of the industry. As a result, 9 new appointments have been made in the last three months alone, adding to a dedicated team of relationship managers, subject matter experts, and data analysts, mandating the need to increase office capacity. Servicing clients across the globe, the team has grown to over 70 working across 2 offices, and the company’s turnover reflects record growth this year.

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.The new premises provide a space for Pharma and CEO companies to perform audit work on site. “Our partnership approach to supporting clients, combined with a proactive culture and strong core values, make it easy for our clients to utilize our office space and do business with us,” continued Patrick Hughes.“Our new offices and increase in employee numbers provide an excellent foundation for continued growth. Our new team members are a talented group of individuals and join an established team that serves clients across the globe.”

King of Prussia and Louvain-la-Neuve are fast-growing business communities. The new locations are well situated for staff and clients alike, as they are close to excellent travel networks and local amenities. 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 done with a risk-based approach, aligned with ICH E6 (R2) and other key industry guidelines.

CluePoints recently announced that the FDA has extended their CRADA until October 2021 and continuing the company’s success, CluePoints has also been selectedas finalists for two prestigious awards – The European Innovation Awards and SCRIP Awards for their Risk-Based Study Execution (RBx) and Data Quality Oversight Software for Clinical Trials. CluePoints were also announced recently as winners of the 2019 GHP Healthcare & Pharmaceutical Awards for Most Pioneering RBM Software Company.

For further information on CluePoints’ solutions, please visit www.cluepoints.com

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
Patrick.Hughes@CluePoints.com
+44 (0) 7703 532 749

FDA Extends CRADA with CluePoints to Further Explore a Data-Driven Approach to Quality Oversight in Clinical Trials

KING OF PRUSSIA, PA, 10 September 2019– FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.  Misconduct in clinical research, including, but not limited to the falsification or omission of data in reporting research results, places all subjects in that trial at possible safety risk.  Fraud jeopardizes the reliability of data submitted to FDA, and undermines the Agency’s mission to protect and promote public health. FDA and other regulators rely on whistle blowers and site inspections to detect signs of possible misconduct.

Due to the volume of product submissions, FDA can only inspect a small proportion of clinical trial sites.  The determination of which sites to inspect can involve recommendations by clinical and statistical reviewers, CDER’s Risk-Based site selection tool and FDA inspectors’ judgment and experiences.

The initial Cooperative Research and Development Agreement (CRADA) between FDA and CluePoints began exploration of a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness.  Under this CRADA, FDA and CluePoints, Inc. have developed and tested enhancements to CluePoints’ existing software to produce an ordered list of “anomalous sites”, i.e. sites whose data are highly inconsistent with data from other sites; added statistical tests and models to those already in the existing software; refined the scoring system used to identify outlying centers; tested and implemented the software in a high performance computing environment; and will continue to develop a user-friendly interface for use by medical reviewers and other interested parties at FDA.

The CRADA has been extended to October 2021 to include additional research focused on “moderators of treatment effect” and real-world evidence. Additional analyses based on these moderators of treatment effect will include geographic region, country and supervising Contract Research Organizations (CROs).

FDA also plans to conduct statistical tests provided by CluePoints such as Key Risk Indicators (KRIs) that will supplement the existing data-driven approach to selecting sites for inspection using a risk-based approach.

Benefits to the FDA of the CRADA’s data driven approach include the detection of anomalous sites which may have escaped detection previously, rapid turnaround of results, the ability to determine the nature and extent of data anomalies, and the ability to explore the interaction of various factors with data quality. These benefits are expected to not only accrue to the site inspection process and improve data quality for all reviewers, but may also inform the efforts of clinical and statistical reviewers to conduct sensitivity analyses, subgroup analyses and site by treatment effect explorations.

For further information on CluePoints, please visit www.CluePoints.com

ABOUT CLUEPOINTS

CluePoints is a 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 the tools needed 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 CONTACT:

Patrick Hughes – Chief Commercial Officer, CluePoints
Patrick.Hughes@CluePoints.com
+44 (0) 7703 532 749

 

 

ICH E6 (R2) Compliance Webinar Series Available to Watch Now!

“I KNOW ICH E6 (R2) COMPLIANCE  INSISTS ON A RISK-BASED APPROACH TO RUNNING MY TRIALS, BUT HOW AM I GOING TO IMPLEMENT THIS AND REALIZE THE VALUE?”

This is the question on everyone’s mind and one that we’ve addressed many times with Sponsors & CROs. This comprehensive two-part on-demand webinar series answers all the questions you’re likely to have about ICH E6 (R2), Risk-Based Study Execution (RBx)/ Risk-Based Quality Management (RBQM) and where the process, people and technology elements are taking us in the future.

What’s to Expect from the Recordings:

PART ONE:
The Different Approaches to Ensure ICH E6 (R2) Compliance

  • ICH E6 (R2) – what is expected of you and why.
  • An overview of the unique situation where regulations insist on us getting more resource and cost-efficient through compliance.
  • Ways to approach the implementation of Risk-Based Quality Management.
  • How much you should rely on your CRO partner to drive the new methodology and how much should you own internally.
  • The functional areas are affected by this new methodology.
  • The tangible cost savings from a reduction in on-site monitoring and SDV.

Watch Part One

PART TWO:
Measuring the Value of Compliance with ICH E6 (R2) and Implementing a Risk-Based Approach to Study Execution (RBx), Best Practice, and the Role of Analytics and Machine Learning.

  • How to put a price on data quality.
  • How to facilitate the Risk Assessment process.
  • How to use Key Risk Indicators (KRIs) to control known risks.
  • How to use Quality Tolerance Limits (QTLs) to help identify systematic issues that could impact patient safety or the reliability of trial results.
  • Best practices for documenting risks and corrective actions.
  • The future of Risk-Based approaches using Machine Learning and AI.
  • How Risk-Based approaches are moving beyond ‘monitoring’ and now include areas such as Risk-Based Data Management & Review.
  • How regulators harnessing a Risk-Based Approach (to site inspections) and where they will see value.

Watch Part Two

If you would like a copy of the slides used in the sessions, please send an email to contact@cluepoints.com.

Parexel Strengthens Risk-Based Monitoring Offering with CluePoints’ New Advanced Statistical Capabilities

Strategic collaboration leverages CluePoints’ Central Statistical Monitoring (CSM) technology to enhance data quality and reduce operational costs.

WAYNE, PA, June 18, 2019Parexel, a leading provider of Clinical, Consulting and Commercial solutions to accelerate the development of innovative new therapies to improve the world’s health, today announced  its strategic collaboration with CluePoints, an industry-leading provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software, to enhance overall data quality oversight and ensure regulatory compliance within clinical trials. Through the collaboration, Parexel and CluePoints aim to drive the quality, accuracy, and integrity of clinical trial data both during and after study conductas well as increase productivity, efficiency and cost effectiveness for sponsors.

“A proactive risk management strategy to protect patient safety and ensure high-quality data is at the foundation of every clinical trial we conduct,” said Gadi Saarony, Executive Vice President and Chief Clinical Research Services Officer, Parexel. “The addition of the CluePoints’ CSM solution enables us to look at Risk-Based Monitoring (RBM) differently and from a holistic point of view so that we can focus monitoring activities where they are needed, ultimately driving increased efficiency and productivity while identifying and addressing risks before problems arise.”

With the adoption of ICH E6 (R2), establishing new requirements to facilitate the mutual acceptance of clinical data by regulatory authorities,there is a greater need to generate higher-quality data in a timely and cost efficient manner. The addition of CluePoints’ CSM technology to facilitate the early identification of anomalous data, optimize on-site and central monitoring and reduce overall regulatory submission risk, coupled with Parexel’s extensive industry experience and RBM expertise, will help to meet the evolving needs of the industry and deliver safe and effective treatments to patients.

“Our vision of RBx, where independent data interrogation, comprehensive analysis, and resulting actions become reusable knowledge, is enabling the industry to progress efficiencies and further improve quality for sponsors,” commented Patrick Hughes, Chief Commercial Officer at CluePoints. “CluePoints is  looking forward to working closely with Parexel’s data surveillance experts to identify, assess, plan, mitigate, monitor and analyze risk across all elements of clinical trial management, using technology to comply with regulatory requirements.”

For further information on CluePoints’ solutions, please visit www.cluepoints.com.

For further information on Parexel, please visit www.parexel.com.

ABOUT CLUEPOINTS

CluePoints is a 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 the tools needed 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.

ABOUT PAREXEL

Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram.

Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.

MEDIA CONTACTS:

CluePoints Contacts:
Patrick Hughes – Chief Commercial Officer, CluePoints
Patrick.Hughes@CluePoints.com
+44 (0) 7703 532 749

Parexel Contacts:
Wendy Ryan
Tel.: +1 781-434-5104
Email: Wendy.Ryan@parexel.com

 

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 www.cluepoints.com.

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.

 

Transitioning from a Risk-Based Monitoring Approach to Risk-based Quality Management

This content was originally posted on Applied Clinical Trials on March 18, 2019

One of the most significant positive changes we have seen recently is the endorsement of ICH E6 (R2) which insists that Sponsors and CROs adopt a risk-based approach to study execution. This paradigm shift in the industry ensures that Sponsors undertake risk assessment during pre-study start-up, implement risk controls and take corrective action during study conduct and keep a full, auditable log of everything that has been done, by who, when and why. What started as an initiative called Risk-Based Monitoring several years ago is now evolving into Risk-Based Quality Management of Clinical Trials with a much wider impact to the Pharma Industry.

  1. Regulatory changes have impacted the industry forcing organizations to re-examine the mechanisms for maximising clinical trial data quality
  2. The way in which organizations are structuring themselves is changing
  3. Pharma organizations are responsible for the quality of data collected through clinical trial execution even when outsourced to a Contract Research Organization (CRO)
  4. Clinical data is now collected from increasing numbers of data sources

As the industry moves to implement Risk-Based Everything (RBX) – a more holistic risk-based approach to quality management – targeted risk management offers the following benefits:

  • Data surveillance exposes issues sooner, with associated communication mechanisms allowing all stakeholders to manage perceived and actual issues to a documented resolution
  • Progress new drugs sooner through development and approval then onto the market with the minimum of operational delays (at least 25% of new drug submissions fail first cycle review due to data quality issues)
  • Enables Sponsors to comply with guidance including giving complete oversight of partners

Technology is making it simpler to collect pre or post-marketing ‘clinical’ data utilizing apps, sensors, wearables and the ever burgeoning ‘Internet of Things’. Today it’s easy to generate ‘data’ on an unprecedented scale that could be valuable in bringing a new drug to market or allow better targeting and utilization for an existing one. While experts predict a long road ahead and many challenges before Pharma evolves from solely being drug providers to being part of the patient solution in collaboration with other stakeholders, a proactive attitude is the only way forward. Integrating RBX software into clinical trials will enable Sponsors and CROs to achieve positive results in terms of significant cost and efficiency savings, as well as giving piece of mind that the data is accurate and conforms to Industry regulations.

A faster adoption of ICH E6 (R2) is needed to ensure compliance with the new regulations and drive much greater efficiency into the clinical trials process. We firmly believe that the comprehensive and independent interrogation of all data using a statistically-driven approach will be a component of every clinical trial in the next three years.

In today’s multifaceted healthcare arena, connectivity, collaboration and cross-functional working has never been more important. This is especially true when it comes to stakeholders. The fundamental goal must always be putting the patient first and the responsibility lies with everyone involved in the Industry, including physicians, payers, providers, policy makers, partners, regulators, and shareholders. How can this be achieved? Those responsible for the delivery of quality in clinical trial execution and the collection of the highest quality data to support development need unified technology solutions that can provide clarity to the management and minimization of risk.

Risk-Based Study Execution (RBx) – It’s Time to Close the Loop!

When the journey started it was all about monitoring. It was about addressing the inefficiencies, rationalizing resources to reduce costs and tackle potential quality issues that could put the clinical trial at risk. “Focus on what really matters” was born, Risk-Based Monitoring was alive.

As more people embark on the journey, it’s becoming less difficult to convince study teams of the value in deploying a risk-based approach to monitoring. This is primarily down to the early adopters that openly shared their positive (and negative) experiences and framed the path to successful adoption. From a rather vague concept, industry leaders reinvented their approach by redefining ancient processes, inventing new roles and implementing tools to better support monitoring activities.

Interestingly, these leaders are now thinking beyond just monitoring. The ICH E6 (R2) has obviously been a great source of inspiration for those considering adopting a risk-based methodology to areas other than monitoring. Data Management and/or Data Review are good candidates, amongst a bunch of opportunities.

The key takeaway here is that as you initiate a new clinical trial and you identify, assess and mitigate your risks (section 5.0 of ICH E6 (R2) is pretty clear that Risk Management applies to all clinical trials), your focus should not only be on how your monitoring activities will be addressing the risks. There are actually a number of unrelated activities that may help prevent or detect potential issues earlier. The resource rationalization and its related ‘focus on what really matters’ concept are equally applicable to edit checks, queries, medical review, safety review etc.,

Here at CluePoints, we’ve experienced customers that didn’t adapt their monitoring strategy at all. Their focus was adopting a risk-based targeted approach to better understand where their risks reside, mitigate them and then adopt algorithmic techniques to monitor these and uncover unexpected issues within the trial data. No reduced SDV strategy but an optimization of their resources to focus on atypical sites, patients or regions, by letting their data ‘speak”

We believe that a good Risk-Based approach relies on three fundamental elements: risk, signal and action. While a risk is something that may potentially happen, a signal is something that actually happened. And as you perform an assessment of these risks and signals, you may decide to act: there is a risk so I take an action (or several) to prevent the risk from happening or ensure its early detection; there is a signal, I take the action of investigating the potential issue and further down the road if the signal is indeed an issue, I take an action (or several) to fix the problem.

From that perspective, Risk Management is a great starting point to author your different functional plans (not just the monitoring plan). Fundamentally, a functional plan is telling you who should do what, when and why. The risk assessment and mitigation processes are giving you exactly that. The risk gives you the reason, the action is telling you what to do, who should do it and when. For example, a high safety risk may imply that 1) my monitor will visit the site every 12 weeks and will focus its SDR on SAEs reporting but it could also imply that 2) my data manager will generate an AEs/Conmeds reports every 4 weeks, that 3) my medical reviewer will dedicate more time on the 5% of the patients with a patient profile reporting an atypically high or low number of AEs and finally that 4) my central monitor with perform statistical data monitoring to identify unusual safety reporting patterns at sites.

But then what? You may have the best plan on earth, you still have to execute it and make sure that your plan ‘works’. Did your mitigation actions reveal problems? Were these problems related to risks that you anticipated or not? How did you find out about these unexpected problems? Should you consider these unexpected risks in future clinical trials? How many of these pre-defined actions were actually ‘useful’? By answering these questions, you are closing the loop. Data, metrics, actions are becoming reusable knowledge.

That’s the goal for the CluePoints team – to establish a community of users sharing their experiences by gathering all the knowledge, processing it with novel analytical techniques (i.e. Machine Learning and Statistics) to make your next clinical trial better, faster and cheaper.

New! Registration Open for CluePoints’ RBM Roadshows – Pick from San Francisco or La Jolla!

We’re delighted to announce that registration for CluePoints’ US Risk-Based Quality Management Roadshow is now open. Taking place in January 2019, these roadshows will provide you the opportunity to network with Industry Subject-Matter Experts and learn more about RBx: A complete risk-based approach to clinical trials.

If like many other sponsors and CROs, especially those with smaller, early-phase studies, your company is unsure how to implement ICH E6 (R2) guidelines in terms of a prioritized, risk-based approach to both quality management and/or monitoring this event will demystify the guidance, leaving you with a clear roadmap on how to achieve the “gold standard” approach. We will explore the following:

  • The key updates within ICH E6 (R2) and how to drive compliance for your organization
  • Why RBx is the future for all clinical studies & the benefits that can be derived from this holistic approach
  • How to ensure that the starting point for your study is a fit for purpose RBx approach based on the size and complexity of your study from Phase I to Phase IV
  • The value in aggregating study data to make better decisions (e.g. Quality Tolerance Limits) based on industry metrics
  • Best practice for study planning and execution, including pre-study risk assessment, risk controls and documented issue mitigation
  • Case studies that illustrate the benefits of using an automated statistically-driven approach
  • Vision of RBx for the next 2 years.

La Jolla, San Diego
Tuesday, January 22, 2019, from 08:00 am to 13:00
Hyatt Regency La Jolla at Aventine
Register Here

San Francisco
Thursday, January 24, 2019, from 08:00 am to 13:00
Hyatt Regency San Francisco Airport
Register Here

These free events tend to book up quickly – be sure to register early to guarantee your place.