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CluePoints Covid-19 Support Benefits Over 200 Clinical Studies Directly Affected by the Pandemic

RISK MANAGEMENT SOLUTION ADDRESSES FDA, EMA, PMDA & MHRA CORONAVIRUS ADVICE

King of Prussia, PA  – May 07, 2020: CluePoints, the premier provider of Risk-Based Quality Management (RBQM) and Data Quality Oversight Software for clinical trials, today announced that its recently launched complimentary COVID-19 risk assessment package and Data Surveillance solution is being utilized in over 200 ongoing studies that are directly affected by Covid-19. The platform, which includes an online Risk Assessment, Risk Mitigation and Data Surveillance solution, is being used to identify, mitigate, resolve and document inherent study risks during this crisis. CluePoints is also analyzing data from several vaccine studies across Europe and North America that are targeting Covid-19.

Addressing the specific recommendations issued by the FDA, EMA, PMDA and MHRA, the CluePoints Covid-19 support package incorporates a focused coronavirus-specific Risk Assessment template that includes a set of relevant risk categories and associated considerations gleaned from the various elements of regulatory guidance. The risk management package includes complimentary access to the CluePoints Risk Assessment Categorization Tool (RACT) for the duration of the crisis alongside a free template to guide users through the new Covid-19 specific risks that are likely evident in most studies. Users also have access to simple online eLearning to allow rapid setup and support via CluePoints Subject Matter Experts (SMEs) to facilitate onboarding. Further, the Data Surveillance tool is helping sponsors and CROs to ensure that no stone is left unturned in identifying and resolving key risks whilst maintaining oversight with new Central Monitoring processes.

CluePoints is already supporting over 50 Covid-19-specific study risk assessments inside the platform. In addition, the team have deployed Covid-19-specific Key Risk Indicator (KRI) dashboards on numerous in-flight trials to enable users to:

  • Add KRIs as needed to focus on important Covid-19 emergent risks, such as those related to missed visits/assessments, missed study treatments, and early terminations.
  • Leverage optimized KRI designs to enable rapid detection of issues emerging specifically during the Covid-19 crisis period.
  • Implement time-window adjusted absolute risk thresholds on KRIs specific to the Covid-19 period.

The Covid-19 package is helping clients to identify, mitigate and control key common risks across studies, any additional study-specific risks, and prioritize by focusing first on studies with upcoming reporting milestones and/or database locks. The CluePoints Data Surveillance solution – which provides advanced KRIs, QTLs, statistical data monitoring, and data visualizations – is giving clients confidence in their ability to effectively monitor their studies even with the current gaps in on-site monitoring.

Commenting on the platform, Patrick Hughes, Chief Commercial Officer of CluePoints said, “Sponsors and CROs are having to adapt quickly in the wake of Covid-19. Assessing risk on new and ongoing studies is a challenge. In a sea of non-compliance, it is important to focus on what matters most – the critical risks and critical data, including incremental versions of KRIs and QTLs. Risk assessment and central monitoring is doubly important during the Covid-19 crisis. The ability to quickly implement a Covid-19-specific risk management solution is offering the industry assurance that key risks can be identified, mitigated and addressed and monitored centrally with confidence.”

Register here to access the Covid-19 Risk Management package. 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

EPS Corporation Signs Groundbreaking Agreement To Drive Increased Quality And Safety Using CluePoints RBQM Solution

King of Prussia, PA  – April 14, 2020: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced that EPS have entered into an agreement with CluePoints to offer Risk Based Quality Management (RBQM) solutions to its sponsors to drive early risk detection, improve quality and enhance patient safety in a cost-effective and resource-efficient manner.

Throughout the global Clinical Research and Pharmaceutical industry, RBQM is fast becoming an essential component to drive efficiency and quality and allowing sponsors and CROs alike to adhere to the regulatory mandates within ICH E6 (R2) published in 2016. CluePoints advocates a unique approach to ensuring regulatory compliance using Central Statistical Monitoring (CSM), an unsupervised, independent and objective analysis of all clinical and operational data. CSM is rapidly being adopted throughout Europe and North American as a proven method to identify risks earlier within the study lifecycle. EPS recognizes that CSM use in Japan can benefit both local and global trials and will be offering the pioneering methodology to all its clients.

EPS will be able to add a suite of RBQM tools to complement either new or existing RBM processes through the CluePoints Central Monitoring Platform. The platform offers a range of tools includes Risk Assessment, Key Risk Indicators, Data Surveillance, Patient Profiles, Data Visualizations, Duplicate Patients and Issues and Actions Management. The combination of these modules provides EPS and its clients with a systemic approach designed to increase the efficiency and effectiveness of study conduct. With guidance from EPS, sponsors are now able to choose the modules that will best suit their needs and that of their studies for successful implementation of RBQM. This approach is also being used by FDA, via a Cooperative Research and Development Agreement (CRADA), to select sites for regulatory inspection and to test treatment effect in different study populations.

Recent announcements by worldwide regulatory agencies such as FDA, EMA, PMDA and MHRA are quick to advocate the adoption of central and remote monitoring techniques in the wake of the COVID-19 pandemic. EPS recognizes that enhancing its own central monitoring capabilities using elements of the CluePoints Central Monitoring Platform will give their sponsors peace of mind that no stone is being left unturned in ensuring that issues are detected as early as possible and managed remotely. This is crucial for business and trial continuity within both new and ongoing studies and will include the use of COVID-19 specific Risk Assessment and Key Risk Indicators for risk planning and mitigation.

Patrick Hughes, CluePoints Co-Founder and CCO commented, “We are delighted to enter into this agreement with EPS as it demonstrates the pioneering approach to increasing the efficiency in conducting trials within Japan. The partnership comes at a time when remote monitoring of studies is the only option and we are keen to demonstrate to EPS and its sponsors how RBQM will improve the conduct of studies, not just at this critical time but for all time”.

Register to access to COVID-19 Risk Assessment package and a CluePoints expert will be in touch. For further information on CluePoints’ solutions, please visit www.cluepoints.com

[About EPS]
EPS continues to contribute to the development of the medical and healthcare industries by constantly transforming and evolving itself, as the name of the company, “Every Progressing System”, shows.
Website: http://www.eps.co.jp

[About CluePoints]
CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. Its 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 Quality Management (RBQM) 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.
Website: https://cluepoints.com/

CluePoints Launches Complimentary COVID-19 Risk Management Package for Clinical Studies

Risk Planning Guidance Addresses FDA, EMA, PMDA and MHRA Coronavirus Advice

King of Prussia, PA  – April 06, 2020: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced that it has launched a complimentary COVID-19 risk management package available to all at no cost. With the FDA, EMA, PMDA and MHRA issuing specific guidelines as a result of the coronavirus, the CluePoints package will help meet these new recommendations and address additional study risks. The platform includes a widely used online Risk Assessment and Control solution that can be leveraged for performing risk planning and mitigation activities addressing inherent risks during this crisis. Register here for the COVID-19 risk management package.

Many clinical trials are facing key challenges, including an increase in missed patient visits, missed assessments, missed study treatments and increased dropouts. Studies are encountering IP supply chain disruptions, recruitment issues and slower site responsiveness. There are gaps in reporting adverse events, less frequent interactions with patients and reduced on-site monitoring visits. The relative scope and impact of these common risks will vary by study, as will the proposed mitigations.

Additional study-specific risks need to be addressed and the regulatory bodies recommend that a fresh risk assessment is performed for each study to identify and mitigate risks pertinent to the COVID-19 crisis. The CluePoints COVID-19 package incorporates a special coronavirus-specific Risk Assessment template that includes a set of relevant risk categories and associated considerations gleaned from the regulatory guidance documents issued by FDA, EMA, PMDA and MHRA. The increased threat of Coronavirus infection may pose a particularly high risk for certain patient populations and/or study treatments (e.g., studies testing immunosuppressant therapies). Further, CluePoints provides recommendations regarding risk controls in the form of specific COVID-19 Key Risk Indicators (KRIs) and will assess each study position before offering advice.

Commenting on the current situation, Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints said,“In the wake of COVID-19, we are hearing that many Sponsors and CROs are struggling to keep up with the need to assess and control risk on new and ongoing studies , with documentation and audit trail even more important in this highly dynamic environment. We currently have over 50 requests from sponsors and CROs to help them implement COVID-19 specific risk management ASAP and over 400 have wanted to hear more about the free offer. At this unprecedented time, we are delighted to play our part by helping all operational teams to manage their studies remotely by doing what we do best, interrogating clinical and operational data in a completely unsupervised fashion.”

The complimentary risk assessment package includes:

  • Free access to the CluePoints Risk Assessment Categorization Tool (RACT) for the duration of the crisis
  • Complimentary guidance supporting users to focus on the new COVID-19 specific risks that are likely evident in most studies and how to control them
  • Access to simple online eLearning (30 mins) to allow rapid setup
  • Support via CluePoints Subject Matter Experts (SMEs) to facilitate onboarding

Hughes continued, “As pioneers in the field of RBM we are able to help, which is why we are offering this package free of charge. We are committed to our clients, and will do all we can to ensure sponsors, CROs and Clinical Technology Partners benefit from constant innovation and transparency.”

Register to access to COVID-19 Risk Assessment package and a CluePoints expert will be in touch. 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 – Co-Founder and Chief Commercial Officer, CluePoints

Patrick.Hughes@CluePoints.com

+44 (0) 7703 532 749

Webinar Recording: The Critical Importance of Early Risk Detection with a Special Feature Addressing COVID-19

We’re delighted to announce that the recording for our COVID-19 webinar has been posted!

About the Webinar

The clinical research industry is in the midst of adopting Risk-Based Quality Management (RBQM) as a primary method for managing quality. RBQM encourages less reliance on traditional on-site monitoring including 100% source data verification/review (SDV/SDR), and greater reliance on centralized monitoring including the use of statistical methods to identify quality-related risks (e.g., unusual or unexpected data patterns).

CluePoints and our clients are accumulating an impressive body of evidence supporting the power of Centralized Statistical Monitoring in effectively detecting emerging issues not only effectively but proactively as well.  Early detection is critical to success, to ensure that corrective actions can be taken in time to prevent significant damage to patient safety, trial outcomes, and related costs.  CluePoints recently conducted “Data Quality Challenge” projects designed to demonstrate the ability of the CluePoints CSM solution to effectively and proactively identify sites with important known quality issues on previously completed clinical studies.  The participating sponsor organizations provided completed clinical study databases to the CluePoints team with the following challenges:

  • Can you identify the problem site(s) that the sponsor team discovered late in the execution phase of the study? The CluePoints team remained blinded to the scope and nature of the known issues, until after the initial analysis was executed on the completed study database and findings presented to the sponsor team
  • How early in the conduct of the study would the CluePoints solution have identified the problem site(s)?

In this webinar, we presented and discussed the results of these data quality challenges, and also provided some key considerations and best practices for ensuring early detection of operational risks and issues and:

  • The added importance of centralized monitoring as a quality monitoring tool in light of the challenges being imposed on site activities and site monitoring by the coronavirus (COVID-19) pandemic.
  • Designing Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for earliest possible risk detection.
Watch the Webinar Recording

Please feel free to share the recording with your colleagues and don’t hesitate to contact us if you need any support, advice and recommendations – contact@cluepoints.com

CluePoints’ Central Statistical Monitoring Supports Business Continuity as Coronavirus Impacts Clinical Trial Operations

MITIGATING THE IMPACT ON SITE MONITORING EFFORTS DUE TO COVID-19

King of Prussia, PA  – March 18, 2020: CluePoints, the premier provider of Risk-Based Trial Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced that it has seen a dramatic increase in demand for remote and centralized site monitoring amid the ongoing Coronavirus outbreak. With sites increasingly proving to be inaccessible across the globe for patients, site staff and/or site monitors, and regulators halting inspections, the biopharma industry is facing many challenges to ensure patient safety, compliance, and data quality and integrity. As the industry strives for business continuity during this global pandemic, CluePoints has mobilized to help its clients overcome some of the blanket travel bans that are impacting operational work (and potentially patient safety) in managing clinical trials effectively. Learn more about Risk-Based Quality Management (RBQM) here.

In recent weeks we have seen the practice of working remotely transform from a “nice-to-have” into an imperative for business continuity. In clinical trials, the mounting restrictions on site visits means that sponsors and their CRO partners are actively seeking alternative, remote approaches to monitoring study conduct, compliance, patient safety and data quality across all participating sites.  Fortunately, eliminating or reducing on-site monitoring visits can happen without significantly impacting trial oversight. CluePoints’ customers, who have ongoing trials that have been affected by these site travel restrictions, have already implemented remote and centralized site monitoring, helping to identify risks early by letting statistical algorithms interrogate the data in an unsupervised manner.

Sponsors can maintain monitoring efforts and oversight remotely by utilizing CluePoints to interrogate the data using its Central Monitoring Platform, with site follow-up by web, phone and email wherever risks are detected. Many customers already using CluePoints are now planning to use this approach on existing trials to ensure patient safety is monitored and data quality and integrity is not compromised, resulting in the avoidance of significant delays. Having less monitors exposed to sites in affected countries can help prevent the spread of the virus too.

Commenting on the current situation, Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints said,“The industry has been steadily moving towards a new paradigm of Central Monitoring, yet the current crisis is forcing more rapid change now. We have an important opportunity to play our part in supporting all patients and stakeholders involved in clinical trials to ensure safety and integrity. As pioneers in the field of RBQM, we continually respond to industry demand, to ensure sponsors, CROs and Clinical Technology Partners benefit from constant innovation and transparency.” Hughes continued, “We’re passionate about maximizing clinical trial data quality, and remote monitoring is one such area that can have a real impact. We’re all worried about the potential effect of COVID-19, on both a business and personal level, but there are simple, easy-to-deploy solutions that remove the need for on-site human intervention that can also help to ensure business continuity.”

Over the last decade, Risk-Based Monitoring has been steadily gaining traction, offering a more efficient and effective quality-control process that can pinpoint with greater speed and accuracy the right information to improve data quality and patient safety. It is at times like these that central monitoring really comes into its own. 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 and believes that risk-based monitoring should be viewed as the new normal. Regardless of global crises, central monitoring oversight platforms offer extended benefits.

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

 About CluePoints

CluePoints is the premier provider of Risk-Based Trial 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 trial 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-trial 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

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.

# # #

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