Monthly Archives

January 2016

TransCelerate’s RACT: How to Deploy the Methodology Efficiently in Clinical Trials

TransCelerate has led the way in conducting research to help sponsors and CROs identify and facilitate the implementation of solutions to drive efficient delivery of new medicines. The organization states that the adoption of Risk Assessment Categorization (RACT) in clinical trials is instrumental in the identification of potential risk factors that may impact studies, and, therefore, delay or halt regulatory submission.

TransCelerate’s methodology provides clarity regarding factors for consideration, but how can the principles be applied to clinical trials efficiently? This is where CluePoints hopes to support the spirit of the initiative. CluePoints free Risk Assessment Categorization Tool – RACT provides an online software product to allow users to identify, interpret and document the risk assessment outcomes per TransCelerate’s methodology.
The CluePoints Risk Assessment Categorization Tool allows users to:

  • Answer questions in term of detectability, impact and likelihood in line with the TransCelerate methodology
  • Customize categories in order of impact, probability, and detectability
  • Customize category definitions, questions, and weight
  • Define reference value fields such as the impact on monitoring plans
  • Document potential risk factors and decisions
  •  Define mitigations and associated KRIs for identified risks
  • Generate a PDF list of actionable items


Transcelerate’s Latest Paper – “Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations”

Pressure is growing for sponsors to implement robust controls to identify data quality issues that may impact trial outcomes, and this is understandable given the number of submissions that fail the first-cycle review due to data discrepancies and the high-profile fraud cases that have emerged in recent years. The growing complexity in trial protocols and regulatory insistence ensures that the required data quality oversight is high priority for most sponsors and their CRO partners. With that in mind, it is clear that adopting a centralized process that will successfully detect potential issues and mitigate risk can greatly contribute to the overall trial success.

Here’s what TransCelerate had to say on the subject in their latest paper – Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations

“Several risk-based methods such as targeted on-site monitoring, central monitoring, and statistical monitoring can assist with detecting these threats to data quality. Although an array of detection methods can be employed, the approach should be tailored to the characteristics of the study to ensure targeted analyses and to reduce the manual burden on those overseeing data quality.”

The TransCelerate paper echoes CluePoints’ stance on the identification and mitigation of data quality issues in clinical trials. It’s our belief that having a centralized workbench to capture study data and operational data coupled with unique statistical algorithms to interrogate data is the smartest and most efficient approach for sponsors and CROs to rapidly identify data quality issues that could put your regulatory submission at risk.

Check out some of the CluePoints case studies to learn more about how sponsors are leveraging the SMART® engine to de-risk clinical studies. Alternatively, pre-register for access to the CluePoints’ Risk Assessment Categorization Tool (RACT) to easily identify and mitigate potential risks in your upcoming studies.

CluePoints is the premier provider of Risk-Based Monitoring Software. Our products utilize 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, EMA, and new ICH (E6) addendum, CluePoints is deployed to support traditional monitoring and data management and can be implemented as the ultimate engine to drive Risk-Based Monitoring. The value of using CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing optimization of central and on-site monitoring and a significant reduction in overall regulatory submission risk. Through experience of working with over 40 customers to date we know that, in a matter of weeks, your team will be able to comprehend fully the potential areas of risk within your study and implement actions to course correct all discrepancies, anomalies and site issues that are surfaced.

CluePoints works in the same way that other industries interrogate data to reduce insurance risk, detect credit card fraud, provide national security intelligence and even select players for sports teams. These sectors rely on this type of comprehensive statistical approach, and the clinical industry is now enjoying the same benefits in terms of risk mitigation, operational effectiveness, and reduced costs.