Following a long standing working relationship between Triumph Research Intelligence (TRI) and the Metrics Champion Consortium (MCC), TRI will now make the IP developed by the MCC’s Risk Management working group available as part of the risk assessment and management module in their OPRA platform. The need for a centralized, easy to use, auditable protocol risk assessment and management capability is becoming increasingly important to companies running clinical trials, especially given the proposed changes to ICH GCP due to be finalized in 2016. The risk assessment and management functionality being developed by TRI will be available as a standalone OPRA module or fully integrated with the risk-based monitoring components, delivering a complete end to end solution. The process of performing a protocol risk assessment and developing resulting quality risk management plans remains a daunting task for many companies. The OPRA solution will ‘hand-hold’ companies through that process, in an easy to use, centrally accessible, cloud based application, and provide the guidance which comes from the MCC’s RAMMT content at the same time. OPRA will also provide that ever important audit trail, creating a CFR21 Part 11 compliant record of who did what in the system, when, and any subsequent changes that might be made during the course of the trial.
“The MCC and its member community have put a huge amount of effort into developing a thorough, robust, yet very usable structure for managing protocol risk, and defining risk management activity as a result.” said Duncan Hall, CEO of TRI. “Taking this information and serving it through the OPRA platform, now means that we are able to make that information available to anyone running a clinical trial, and to provide continuity of process and data, through risk assessment, risk planning, risk management and ultimately risk- based monitoring. With the upcoming changes in ICH GCP, there is going to be a lot of focus on risk assessment and risk management in clinical trials, and we’re poised ideally to support the industry and make sure that companies are able to not only be guided through the risk assessment and management processes, but be able to prove they are doing so. Not only will this be of value to any current study, but it will allow companies to build up a searchable history of risk management activity and continually improve by learning from what they’ve done on previous studies.”
“We are pleased to announce that TRI is the first organization to be part of the new MCC Solution Provider program. Our members are looking for innovative ways to implement and effectively utilize the standardized metric sets and tools developed in our collaborative working groups – the Solution Provider program sets the stage for MCC to work with IT companies interested in integrating MCC IP into their product offerings,” said Linda Sullivan, Co-Founder and President of MCC. “TRI has been an active member of the consortium over the last several years, especially in the Risk-based Monitoring Working Group. The group benefited from their willingness to share insights about their experience of working with sponsors, CROs and regulatory authorities as they developed their RBM product, OPRA. We look forward to working with them in the Solution Provider program.”
About Triumph Research Intelligence (TRI)
Built on the foundation of Triumph’s 14 years of consulting exclusive to the clinical trials industry, TRI was established in 2013 in order to address the growing regulatory need for the industry to be able to provide evidence of quality risk management, quality oversight and decision making traceability during clinical trial execution. TRI’s OPRA platform has been designed from the ground up, specifically for this purpose and provides an accessible, affordable, hosted and fully 21CFR part 11 compliant environment for quality oversight and riskbased monitoring. Understanding that quality oversight and RBM is not just about technology, TRI provides a full suite of RBM specific services for companies wishing to start or improve on their RBM capabilities. These services include risk assessment, training, KRI design, change management and technology implementation. Our mission is to improve trial efficiency, quality and patient safety through the practical application of our technology and professional services. For more information, visit www.tritrials.com.
About The Metrics Champion Consortium (MCC)
MCC is a trusted partner in the clinical trials industry to identify what to measure and assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. We continually bring you new insights into the leading trends within the industry. For more information, visit www.metricschampion.org.