CluePoints’ Risk-Based Monitoring Solution Receives Clinical Informatics News Best Practices Award

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Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring solutions for clinical trials, today announced that it has won a Clinical Informatics News Best Practices Award for “creating the ultimate Risk-Based Monitoring and Data Quality Oversight Solution.” The Clinical Informatics News Best Practices awards recognize outstanding examples of applied strategic innovation-partnerships, deployments, and collaborations that manifestly improve the clinical trial process. CluePoints is delighted to receive another accolade recognising the considerable efforts of all staff members. We are committed to driving better quality into clinical trials and creating a company that is fun to work for and with.

Since conception, CluePoints has been known for breaking new ground as an enabling technology for Risk-Based Monitoring (RBM), CluePoints’ Central Statistical Monitoring (CSM) software utilizes statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. Deployed to support traditional monitoring and data management as well as improved “risk-based approaches,” CluePoints’ CSM software can be implemented as the ultimate engine to drive Risk-Based Monitoring. The value in the solution lies in its ability to identify anomalies in data earlier, offering the opportunity to eradicate issues as they are uncovered, increasing patient safety and reducing risks of data quality and integrity issues when submitting regulatory approval.

In addition, CluePoints recently announced that they signed an agreement with the US FDA to explore a data-driven approach to quality oversight in clinical trials. This Cooperative Research and Development Agreement (CRADA) explores a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness. Anticipated 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, the ability to explore the interaction of various factors with data quality.

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The FDA is Knocking at your Door – Are you Ready for an FDA Site Inspection?

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Are you ready for an FDA site inspection?

You may have heard that CluePoints signed an agreement with the FDA. This Cooperative Research and Development Agreement(CRADA) explores a data-driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness. This shouldn’t come as a shock, since The FDA has been very vocal about their stance on Risk-Based Monitoring1

In 2015, The FDA issued 17,2322 warning letters, that’s a whopping 92% increase on letters sent out in 2014. The statistics reinforce the fact that investigators are interrogating sponsor’s data and protocols more thoroughly than ever before. Now, picture this, The FDA is knocking at your door – can you say that you’re 100% confident that your clinical trial data meets the recommended standard set out by the FDA? If not, it’s time to take preventative action.

CluePoints’ RADAR™ service enables sponsors to achieve a data-driven understanding of risks upon which to base high-impact site inspection readiness activities. Our Data Analysts will undertake a comprehensive statistical analysis of trial data using CluePoints’ software to provide sponsors a ranked list of the most anomalous sites, highlighting the areas of risk across site and patient data.

Download CluePoints’ RADAR™ data sheet to learn how we can help you identify clinical sites that may be selected for inspection.

1 FDA Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to  Monitoring

2 FDA Enforcement Statistics Summary Fiscal Year 2015

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Risk-Based Monitoring Software

Webinar: Risk-Based Monitoring Implementation – What does ICH E6 Rev2 Mean for My Company?

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With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to ensure appropriate consideration of risk in study design and management.

For this webinar, CluePoints is again teaming up with Paragon Solutions, to highlight the key changes in the mandate and explain how best to address these elements for successful Risk-Based Monitoring Implementation.

Expect to Learn:

  • Understanding the key ICH E6 updates related to Risk-Based Monitoring/Data Quality Oversight and their purpose
  • Understanding how Central Statistical Monitoring(CSM) and Key Risk Indicators(KRIs) will work for you
  • Critical-to-success methods for Central Statistical Monitoring and KRIs
  • Change Management – Using E6 R2 to support your organization’s transition to RBM
  • The Monitoring plan – not just for monitoring intervals anymore

When:

Tuesday, March 14th, 2017, 3:00pm GMT/ 11:00am EDT/ 08:00am PDT (Timing reflects  daylight savings time)

CluePoints – Finalists in The Clinical Informatics News 2017 Best Practices Awards at SCOPE, Jan 24th – 26th in Miami

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We’re thrilled to announce that CluePoints has been named as finalists for the Clinical Informatics News 2017 Best Practices Awards, for our award-winning Risk-Based Monitoring and Data Quality Oversight Solutions. The Clinical Informatics News Best Practices Awards recognize outstanding examples of applied strategic innovation – partnerships, deployments, and collaborations that manifestly improve the clinical trial process.

The winners will be announced at the SCOPE Summit for Clinical Ops Executives in Miami, Florida on January 25, 2017 – wish us luck!

The nomination for this award follows news that CluePoints signed a Cooperative Research and Development Agreement (CRADA) with the FDA. This Cooperative Research and Development Agreement (CRADA) explores a data driven approach to selecting sites which exhibit anomalies indicative of fraud, misconduct or sloppiness.

Also, be sure to stop by our booth (#509) at SCOPE to learn more about Risk-Based Monitoring, Data Quality Oversight and how our agreement with the FDA is driving how the regulator is interrogating submission data to select sites for inspection.

See you there!

CluePoints CEO, Francois Torche, to Present at SCOPE Summit for Clinical Ops Executives

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The 8th Annual SCOPE Summit for Clinical Ops Executives, taking place on January 24-26, 2017 in Miami, FL, will offer three stimulating days of in-depth discussions in 13 different conferences, six pre-conference workshops, and two symposia focused on issues related to each aspect of clinical trial planning and management.

Francois Torche, CEO, CluePoints will lead a session entitled “RBM Demystified: What We’ve Learned from the Practical Implementation of RBM and what the Regulators Want.” The session will take place on Wednesday, January 25th at 11:40 am.

Key objectives for Francois’ session include:

  • Best practice for Risk-Based Monitoring study planning process
  • Key pitfalls to avoid
  • How to differentiate between risk assessment, Key Risk Indicators (KRIs), and Data Quality Oversight Methods
  • How other Sponsors and CROs are leveraging a Risk-Based approach to monitoring and satisfying regulatory requirements

If you haven’t signed up for SCOPE Summit for Clinical Ops Executives, you can save $200 on registration using the following discount code: CLUE

Also, be sure to stop by our booth (#509) to explore the data-driven approach to quality oversight and learn more about how our recent agreement with the FDA is driving how the regulator is interrogating submission data to select sites for inspection

See you there!

Secrets to Successful Risk-Based Monitoring Webinar Poll Results

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Thank you to all who registered and attended CluePoints’ recent webinar with Paragon Solutions: The Secrets of Successful Risk-Based Monitoring Revealed. We hope that you found the webinar informative. Below you will find the poll results and the documented Q&As. The on-demand recording can be viewed here. Enjoy!

The Poll Results

1: How aware is your company of the Risk-Based Monitoring approach to study management?

We are actively planning to implement an RBM strategy

24%

We have announced our plans to move to RBM strategy

18%

We have implemented RBM strategy

37%

We have not assessed RBM approach yet

20%

What is RBM?

1%

2: How many clinical systems are used to manage studies and data today?

1

5%

2-4

62%

5-10

26%

10+

7.9%

3: When you send out communications across your enterprise, what term do you use to describe this approach?

custom coined term

2%

Adaptive Monitoring

12%

Quality by Design (QBD)

7%

Reduced SDV

7%

Risk-Based Monitoring

72%

4: How many KRIs have you defined as standard/core for your enterprise?

5 or less

42%

5-10

34%

11-20

9%

20+

2%

We have not defined any standard/core KRIs

13%

The Q&A

1: Any data related to studies inspected by USFDA which had Risk-Based Monitoring approach against the traditional monitoring approach?

While there is no public domain data available on the success or failure of submitting an RBM study to the FDA – there is good data on the challenges in the existing model:

  • About 50% of sites fail to reach the planned recruitment targets.*
  • The majority if not all milestones missed in the clinical trials—more than 95% of clinical trials do not end on time and on budget as planned in the first place.*
  • 90% of the studies meet their recruitment goals, but at the expense of mostly twice as much time as originally planned.* The costs attributable to these delays are gigantic.
  • Too many avoidable protocol amendments, with a first amendment implemented even before the very first patient has been enrolled—most of them due to the rush towards “First-Patient-In”.

In addition, an analysis published by TransCelerate in 2014 (Steve Young was a co-author) revealed that – on average – only 1% of site-entered eCRF data gets corrected by the traditional approach of 100% on-site Source Data Verification and Review.**

* Tufts Center for the Study of Drug Development Impact Report “New Research from Tufts Characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices”. 15 (1), January/February 2013.

** Therapeutic Innovation and Regulatory Science “Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials”. November, 2014

2: If you were to use a single term that incorporates QBD and RBM but not use those in particular what do you suggest?

We like the ICH term of Quality Risk Management (QRM) – it is a broader term that encompasses the larger paradigm shift that is needed for this transition.

3: What do you think on implementing RBM in ClinPharm studies? Have companies implemented it in CP studies? (i do not mean FIH studies)

We strongly believe that the QBD and RBM approach should apply to any and all clinical research, including ClinPharm studies.  In particular, the approach of identifying and mitigating risk through study design, study planning and execution is simply the appropriate way to approach clinical research.  However, some of the operational details will look different depending on the study type.  For example, some of the more intensive statistical monitoring methods may not apply to studies of very short duration or with very few sites.  Similarly, the level of on-site monitoring and SDV/SDR will likely vary by study.

CluePoints Partners with Metrics Champion Consortium to Define Metrics and Standards for Centralized Monitoring

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8 November 2016

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) and Risk-Based Monitoring(RBM) solutions for clinical trials, announces its partnership with the Metrics Champion Consortium (MCC), an association dedicated to the development of standardized performance metrics to improve clinical trials. Drawing on the company’s vast expertise in Risk-Based Monitoring, CluePoints will work with the consortium to help drive collaboration in the development of a standardized framework for Central Monitoring, including identification and definition of what is included, who should be involved, and how best to manage the process.

“We are excited to have the opportunity to lead such an important initiative for the Metrics Champion Consortium” comments Steve Young, Senior Vice President of US Operations at CluePoints. “The industry is finally beginning to move forward to large scale adoption of RBM, yet there remain many questions on the topic of Central Monitoring, and so we look forward to driving clear guidance and standards for this critical component of RBM success.”

The Metrics Champion Consortium has created the Central Monitoring work group to help facilitate the exchange of knowledge and expertise in standardization of clinical risk management. Known for organizing work groups with the intention of providing metrics for the clinical trials industry, MCC has engaged CluePoints to work with them to more clearly define what Central Monitoring is for the industry.

“We are delighted that CluePoints will lead our Central Monitoring work group” comments Linda Sullivan, Co-Founder and President of Metrics Champion Consortium. “Results from our recent Risk-based Approaches to Monitoring Industry Survey show an increasing number of organizations use/plan to use central monitoring approaches in the next 12 months as compared to two years ago. This new MCC work group will bring sponsors, CROs, central & core labs, consultants and IT system vendors together to explore what key risk indicators, performance metrics and data should be included in central monitoring, what analytic approaches should be used to gain valuable insights and how organizations should use the insights to ensure patient safety and improve data quality. CluePoints’ experience with centralized monitoring and risk-based monitoring make the company ideally placed to bring the community together to share insights and align thinking to established, shared global standards.”

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

About CluePoints

CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

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

About the Metrics Champion Consortium

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

For more information about MCC publications, metric sets & tools, metric education programs and how you can participate in future surveys and MCC work groups, please visit http://www.metricschampion.org

Contacts:
Linda B. Sullivan – President, Metrics Champion Consortium
Lsullivan@metricschampion.org
+1.317.622.0266 ext 102

CluePoints Introduces Data Quality Oversight Service for Site Inspection Readiness

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31 October 2016

Cambridge, MACluePoints, a leading provider of Risk-Based Monitoring (RBM) and Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced a new Data Quality Oversight service, RADARTM, aimed at helping sponsors achieve a data-driven understanding of risks to an inspection-ready level. As regulators insist that sponsors adopt more comprehensive quality oversight methodologies, this new service looks to move away from antiquated processes to a more rigorous statistical approach to operational quality assurance including preparation for site inspections.

CluePoints’ RADAR™ service harnesses the advanced statistical interrogation of clinical and operational study data to identify investigative sites with a preponderance of anomalous, missing or inconsistent data that may require inspection readiness action. The company’s Data Analysts conduct a comprehensive assessment using the software to identify these higher-risk sites and data which may have escaped detection previously. This rigorous approach is anticipated to benefit sponsor submissions by identifying anomalous sites along with the nature and extent of potential data issues.

“The launch of our ground-breaking RADAR service marks another exciting development in data quality-driven risk analysis. This unsupervised, independent solution will help clinical research organizations to move away from existing time-consuming, approximate and costly procedures” comments Franҫois Torche, CEO, CluePoints. “It analyzes data trends over time to help comply with regulators’ standards, ensuring data quality and ultimately mitigating risks and improving the safety of patients.”

Inspiring confidence throughout the process, this service is an extremely cost-effective alternative to traditional site inspection readiness planning. It provides a report that ranks the most anomalous sites, identifies areas of risk across site and patient data and anticipates where regulators might also target their site inspections. Companies are adopting the RADAR service to use across Clinical Operations, and now in particular for Clinical Quality, Auditing, and Inspection Readiness.  Sponsors can access all these benefits through CluePoints’ outsourced service approach, and alternatively can obtain the CluePoints’ platform for internal, enterprise level adoption.

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

About CluePoints
CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

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

 

FDA Signs Agreement with CluePoints to Explore a Data-Driven Approach to Quality Oversight in Clinical Trials

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12 October 2016

Cambridge, MA –  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 whistleblowers 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.

This Cooperative Research and Development Agreement (CRADA) explores a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness.  Under this CRADA, FDA and CluePoints, Inc. will develop and test 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; explore “moderators of treatment effect”, i.e. factors such as center, region, or country that have a statistically significant impact on the magnitude of treatment effect; add statistical tests and models to those already in the existing software; refine the scoring system used to identify outlying centers; add an exploratory tool to identify moderators of treatment effect; test and implement the software in a high performance computing environment; and develop a user-friendly interface for use by medical reviewers and other interested parties at FDA.

Anticipated 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 Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

Media Contact

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

CluePoints Teams up with Paragon Solutions to Share the Secrets of Successful Risk-Based Monitoring Implementation

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CluePoints and Paragon Presents: The Secrets of Successful Risk-Based Monitoring Implementation Revealed

We’re delighted to announce that are our next Risk-Based Monitoring implementation webinar is open for registration! Register now – this is THE Risk-Based Monitoring webinar that you need to attend.

About the Webinar

With regulatory bodies such as the FDA, EMA, and the ICH all strongly influencing sponsors to adopt a risk-based and centralized approach to site and data monitoring, sponsors are often left wondering how to implement this new paradigm most effectively.

For this webinar, Steve Young, Senior Vice President of US Operations, CluePoints,  is teaming up with Karen McCarthy Schau, Principal Consultant, Paragon Solutions, clinical and regulatory experts to the Life Sciences industry, to arm you with all the information you need to plan, document, implement, and evolve a bullet-proof Risk-Based Monitoring strategy.

In this session, we will be laying the foundation for implementing RBM.

Key Takeaways

  • How to structure your organization to support Risk-Based Monitoring
  • How to determine what solutions/capabilities you need to do RBM
  • How to introduce your team to the concept of QBD and risk assessments
  • How to define KRIs and data points to support monitoring

Date and Time

Tuesday November 8th, 2016, 10:00 AM EDT/ 3:00 PM GMT