TRI and the Metrics Champion Consortium (MCC) announce the integration of the MCC's Risk Assessment and Mitigation Management Tool (RAMMT) with TRI's OPRA Risk-Based Monitoring and Quality Management Platform. TRI - Where's the Risk?

1. Press Release
16th
January 2016
FOR IMMEDIATE RELEASE
TRI and the MCC announce the integration of the MCC’s Risk Assessment and Mitigation
Management Tool (RAMMT) with TRI’s OPRA Risk-Based Monitoring and Quality
Management platform.
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

2. Press Release
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.”
Additional Information
About Triumph Research Intelligence
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 risk-
based 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 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, please visit www.metricschampion.org
MCC Contact:
Teresa Holland

3. Press Release
Metrics Champion Consortium
+1 (317) 622-0266 ext. 108
tholland@metricschampion.org