OPRA- Operational Platform for Review, Reporting and Analysis, is a cloud-based, easy to use, purpose-built operational platform that allows clinical study teams to identify and manage clinical study site quality risk, a critical component of the clinical trial monitoring approach now recommended by the FDA and EMA.

1. Media Contact
Kendal Quinn
Triumph ResearchIntelligence Ltd.
Kendal.quinn@tritrials.com
919-879-4458
PRESS RELEASE
FOR IMMEDIATE RELEASE
Tuesday 7th April 2015
TRI ANNOUNCES OPRA – SaaS RISK-BASED MONITORING (RBM) PLATFORM
OPRA- Operational Platform for Review, Reporting and Analysis, is a cloud-based, easy to use,
purpose-built operational platform that allows clinical study teams to identify and manage clinical
study site quality risk, a critical component of the clinical trial monitoring approach now
recommended by the FDA and EMA.
OPRAis the first and only platform in the RBM domain that has been designed exclusively for
quality oversight and Risk-Based Monitoring.
RALEIGH, NORTH CAROLINA –
The Risk-Based Monitoring platform, OPRA- Operational Platform for Review, Reporting and Analysis,
has beendeveloped by Triumph ResearchIntelligence (TRI), based in London, UK and Raleigh,USA.
OPRA employs a unique combination of statistical calculations, data visualizations and operational
activity management to fill a long existing regulatory gap in the market. This gap has beendriven by
regulatory requirements surrounding the RBM approachthat the clinical trials industry has beenin the
process of adopting for the last two years. Regulators have beenespecially frustrated with the lack of
evidence that companies have beenable to provide related to ensuring the study protocol is followed
properly, that a risk managementplan has beendeveloped and followed and ultimately that patient safety
is maintained above all else.
In general terms, OPRA uses data from the systems where trial data is typically stored to search for
patterns and outliers in the data. The patterns are displayed to users in easy to read graphs which show
how eachsite relates to the others within a set of data. Combinations of patterns yield a “signature” that
provides insight into the behaviorof the site attending to patients in a clinical trial. Identifying these
signatures allows users of OPRA to assess the risk that the site poses to the patients and to the trial
based onseemingly unrelated data already collected from the site.
Risk detectionis only part of what the regulators require though and it’s the action and evidence process
part where many companies are failing to meet regulatory expectations. In order to meet this expectation,
OPRA allows users to record their observations (i.e., what they interpret, suspect, or need to investigate)
at assessmentpoints during the trial. Users can also track actions related to the observations so that
specific tasks may be delegated and tracked in the system.
As the trial continues, additional data is collected and the sites are evaluated periodically. Hopefully the
previous mitigating actions have had a positive effect. Here again, the regulators have had found a
troubling lack of evidence that companies know the effect of the actions they took or if the quality
managementplan has been followed at all. Not only does OPRA keep track of the actions but it will show

2. the trend of the risk ratings overtime along with the actions taken plotted on the same graph. This graph
makes it readily apparentif the site is improving its score and demonstrates the management of risk for
the trial.
Larger trials can easily run for three years or more. At some point, the regulators will want to see
evidence of the risk assessments and mitigating actions that took place months and years a go. A
company that cannot provide that level of insight may be cited for inadequate protection of patient safety .
By using OPRA, companies can integrate the ongoing detection, action and managementof site quality
risk into the clinical trial process while providing the regulatory agencies the evidence of quality oversight
they require and protecting the participating patients.
OPRA is easy to implement and use. TRI provides fully compliant and secure hosting with the SaaS
offering and the pricing model is simple. Study setup is no more than a few days and OPRA requires
nothing more than an internet browser for user access. There are no limits on the number or types of
source systems; as long as the data is available insome electronic form, OPRA may be used to manage
quality.
OPRA has been purposefully designed to closely alignwith the guidance set out for RBM by the industry’s
top organization for cooperationamong pharmaceutical companies, TransCelerate BioPharma.
TransCelerate BioPharma Inc. is a non-profit organization focused on advancing innovation in research
and development(R&D), identifying and solving common R&D challenges and further improving patient
safety, with the goal of delivering more high quality medicines to patients. The cooperationand
standardization that an organization like TransCelerate BioPharma brings to the industry is invaluable for
the adoptionof a change as significant as Risk-Based Monitoring. TRI has recently released analignment
paperwhich details exactly how OPRA meets the TransCelerate BioPharma guidance
(http://tritrials.com/transcelerate-alignment/). The designdirection TRI has taken with OPRA has also
beeninfluenced by the direction that the FDA, EMA and Metrics Champion Consortium (MCC) have taken
with their Risk-Based Monitoring guidance. TRI is an active participant in the MCC and acts as an advisor
to the MCC’s RBM working group.
Several top companies in the industry are piloting their RBM programs with OPRA at this time and the
learnings from those pilots are already being used to direct the next evolutions of the platform. TRI’s CEO
and founder, Duncan Hall stated, “we are already on the third evolution of the OPRA product and currently
planning our fourth. The conceptof evolution is about learning and adapting to one’s environment over
time, and that is exactly what we are doing with the OPRA platform. The more trials we run, the more we
learn, and the more quickly we are able to evolve OPRA to better meet the needs of the industry. We
don’t believe in software releases,we believe in evolution.”
Through the experience gained in assisting the industry in RBM pilots, TRI has learned that the successful
adoptionof RBM is not just about implementing software but about changing business processes,roles
and relationships. It is about the better use of clinical data earlier in clinical trial process.Ultimately, the
adoptionof RBM is a change program for any organization, and TRI prides itself in being the only
company to take a holistic approachto RBM where we not only offer a RBM specific software, but also the
operational,training and change managementservices required for any organization wishing to
successfully implement a RBM program.
Learn More about OPRA and accompanying RBM services on TRI’s web site at:
www.tritrials.com
If you would like to schedule an interview with TRI’s CEO and founder, Duncan Hall, please use
the form on the “Contact Us” page of our website or email info@tritrials.com