CAMBRIDGE, Mass.—Aimed at meeting the latest global regulations for conducting clinical trials, CluePoints, a software provider of risk-based monitoring (RBM), has launched a collaboration with Widler & Schiemann Ltd., working in the area of quality management in clinical trials and drug safety.
Peter Schiemann, managing partner and co-founder of Widler & Schiemann, tells DDNews that the EU Clinical Trials Regulation will be applicable as of early 2017.
The new EU Clinical Trials Regulation will streamline the authorization process and harmonize requirements for clinical trials in Europe, ensuring risk management and quality management while maintaining safety for participants, according to an international steering committee report.
“We are delighted to be collaborating with CluePoints to provide customers with a true end-to-end solution that helps them in the complete risk assessment of their quality management in clinical trials,” Schiemann stated in a news release. “As well as helping customers harness the power of the CluePoints solution in the most effective way possible, we can ensure that they do so in line with the (GCP ICH E6) guideline, including its new amendment and the new clinical trial regulation that is due to come into effect soon.”
“Evolutions in technology and risk management processes provide new opportunities to enhance the efficiency of clinical trials and focus on relevant activities,” Schiemann tells DDNews. “The [GCP ICH E6] guideline has been amended to encourage the implementation of improved and more efficient approaches to clinical trial design, conduct and oversight, while continuing to ensure patient safety and data integrity.”
According to Schiemann, the amended guidance includes a new chapter on risk-based monitoring and the requirements when implementing the approach.
Upgrading guidelines around performing clinical trials has become a polarizing issue, pitting members who believe stricter practices are the best protection against errors and security risks against other members who contend that passing more guidelines in conducting preclinical trials is not only time-consuming, but costly.
Although ICH E6 generally can be interpreted as providing sponsors flexibility to implement innovative approaches, it has been misinterpreted and implemented in ways that impede innovation by, for example, emphasizing less-important aspects of trials (e.g., focusing on the completeness and accuracy of every piece of data) at the expense of critical aspects (e.g., carefully managing risks to the integrity of key outcome data), according to the steering committee.
Ideally, the international committee would like a “harmonized guideline on approaches to quality management for clinical trials, including risk-based monitoring and supporting the use of new technology which could have a similar impact on the protection of trial participants and the reliability of trial results. Prioritized, proactive quality-management approaches to clinical trials are supported by industry to ensure data quality and human subject protection.”
CluePoints’ CEO, Franҫois Torche, said in a prepared statement: “We work with many customers who are looking for strategic advice on adapting their organization and updating their internal policies to meet the needs of new RBM strategies. By bringing in the consultancy expertise of Widler & Schiemann, we can work together to support customers and ensure they have both our industry-leading software and the expertise and guidance necessary to successfully implement a comprehensive risk-management solution.”
“Until recently, clinical site monitoring has almost exclusively been carried out via routine site visits every four to eight weeks, using 100 percent Source Data Verification,” Torche explains to DDNews. “This antiquated process can account for over 30 percent of a sponsor’s overall costs (equating to tens of millions of dollars), whilst resulting in less than 3 percent post-visit data changes—a high price to pay for little gain.”
“As budgets become more difficult to manage and data issues grow, regulatory authorities and most in the industry no longer believe that this approach represents the best solution,” he adds.
According to Torche, CluePoint’s RBM solution uses an independent and objective statistical methodology to identify anomalous clinical and operational data in trial databases. The approach uses a large number of statistical tests and scoring algorithms to identify investigative centers whose data are inconsistent with data from other centers taking part in the same trial.
“As a consulting company in quality management, Widler & Schiemann will collaborate with CluePoints to provide clients with a service to assist them in interpreting the data generated by the RBM software,” he says. “Widler & Schiemann will also deliver change management consultancy to prepare clients for the move to the approach, as well as advice on procedures and best practice guidance for successful implementation.”
Widler & Schiemann’s experts work with clients to identify how workflows, processes and systems need to be adapted to support more targeted approaches to monitoring in clinical trials. The company’s services complement CluePoints’ Central Statistical Monitoring software, which provides an agnostic approach to RBM by using statistical methodology to identify unexpected patterns in trial databases and focus monitoring efforts, Torche noted, adding that the software also defines and deploys key risk and key performance indicators, allowing sponsors to set their own subjective thresholds. Combining the expertise of the two companies will offer customers a complete risk-management solution with expert guidance on how to implement CluePoints’ software, helping improve trial oversight while driving quality and patient protection.