Monthly Archives

March 2020

Complimentary COVID-19 Risk Assessment Package Available To All at No Cost

COVID-19 Risk Planning

As advised in the coronavirus guidances recently issued by FDA, EMA, and MHRA, it is important to perform a fresh risk assessment for each study to identify and mitigate risks pertinent to the COVID-19 crisis.  Your organization is likely already aware of key challenges that will be common to most if not all clinical studies, such as the following:

  • Increase in missed patient visits
  • Increase in missed assessments even for patient visits that occur
  • Increase in missed study treatments, for various reasons including missed patient visits and IP supply chain disruptions.
  • Increase in patient early terminations (“study drop-outs”)
  • Difficulty recruiting new patients
  • Slower site responsiveness, including delays in EDC data entry and query response.
  • Gaps in reporting of adverse events, especially to the extent that sites will have less frequent interactions with their patients.
  • Less frequent on-site monitoring visits

However, the relative scope and impact of these common risks will vary by study, as will the proposed mitigations.  Additional study-specific risks may also need to be addressed.  For example, 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).

The CluePoints platform includes a mature online Risk Assessment solution that can be leveraged for performing risk assessment and mitigation planning during this crisis.  Our team of experts have also developed 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 and MHRA.

The image below illustrates this CluePoints COVID-19 Risk Assessment template – click the image to enlarge.

Here's what you will Receive from CluePoints if you Request our Support

  • Free access to the CluePoints Risk Assessment and Categorization Tool (RACT) for the duration of the crisis
  • A free template to guide you through new COVID-19 specific risks that are likely evident in most studies
  • Access to simple online eLearning (30 mins) to allow rapid RACT set-up
  • Support via CluePoints Subject Matter Experts (SMEs) to facilitate onboarding

How to get Access to the COVID-19 Risk Assessment Package

Getting started couldn’t be easier. Click the button below to send your details and one of our experts will follow up with you to get you set up with the COVID-19 Risk Assessment Package.

Register for Access to the COVID-19 Package

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.

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Media Contacts:

CluePoints Contacts:

Patrick Hughes – Chief Commercial Officer, CluePoints

Patrick.Hughes@CluePoints.com

+44 (0) 7703 532 749

Registration Open for our Risk-Based Quality Management Insights Webinar

Please join us for our March 31, 2020 webinar:

RBQM Insights – Understanding the Critical Importance of Early Risk Detection (With a Special Feature Addressing COVID-19)

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 and partners are accumulating an impressive body of evidence supporting the power of Centralized Statistical Monitoring (CSM) 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 damange to patient safety, trial outcomes, and related costs.  CluePoints in fact 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 challenge:

  1. 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
  2. How early in the conduct of the study would the CluePoints solution have identified the problem site(s)?

In this webinar, we will present and discuss the results of these data quality challenges, and also provide some key considerations and best practices for ensuring early detection of operational risks and issues:

  • 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

HOW TO REGISTER FOR THE WEBINAR:

We are running two sessions to cater to different timezones:

Tuesday, March 31 at 10 AM BST/ 11 AM CEST
REGISTER

Tuesday, March 31 at 2 PM EDT/ 11 AM PDT
REGISTER

If either of the above sessions don’t work with your schedule, please register for one of the sessions and we will send the recording to you.