TRI Technology

 

OPRA RAM is the industry-leading risk assessment and management tool.  Fully validated and web-based, it gives quick, easy and intuitive access to your whole team, wherever they are in the world. 

 

That means your risks are always up-to-date and it's easy to produce a regulatory compliant report at any time on the changes made, decisions taken and actions to mitigate and manage risks, right throughout the whole of your clinical trials.

10 key benefits from using OPRA RAM

  1. Extremely cost effective with a quick and demonstrable return on investment

  2. Quick and easy to train and deploy - be up and running in less than an hour

  3. Simple, intuitive interface - it's quick and easy to create and manage risks

  4. Graphical dashboards for rapid identification of trends and problems

  5. Easy reporting - single click export of all charts and data lists, and fully formatted PDF reports for inclusion in TMF

  6. Version control - one version that evolves throughout the study

  7. Configurable risks and risk control libraries for re-use in future studies

  8. Easy access to all ongoing and historic risk assessments for corporate learning and knowledge retention

  9. Web-based, user access controlled, 21 CFR Part 11 compliant

  10. Fully validated and audit ready

 

OPRA CM is an easy-to-use web-based platform for the management of clinical trial quality through central and risk-based monitoring.

Designed specifically to run ICH E6 (R2) compliant studies, it combines data visualisation, business intelligence, data aggregation, data review, statistical modelling and operational activity management in a single environment for study teams to manage trial quality efficiently.

Fully validated and 21 CFR Part 11 compliant, it has powerful features like data ‘roll back’ to show data as it was at previous points in the trial history, a great benefit during inspections, audits and in Sponsor/CRO communications.

10 key features in OPRA CM

  1. Central & Risk-Based Monitoring - OPRA delivers full support for both approaches

  2. Dynamic User Interface - Gives users the exact data view they want, quickly and easily

  3. Study & Site Dashboards - View study data at the level you need, including the ability to drill down to site and patient level data to perform data reviews and make better, data-driven decisions

  4. Source Data Agnostic - Access data from multiple sources to give users the full study picture

  5. KRI Library - Chose from 20 industry standard and pre-validated indicators, or create protocol specific KRI's with the ability to configure thresholds and weightings

  6. Integrated Statistical Models - Our KRI's use a range of statistical models that deliver a rich range of data visualisations

  7. Quality Trend Analysis - Review study and site data over different time periods to assess the impact of different decisions and actions 

  8. Historic Data Views - Roll back data to any point in the trial history to see how the data looked at that time to support why decisions were made and actions taken

  9. Audit Trail - A complete, searchable audit trail shows who did what and when

  10. Compliance - OPRA has been through a full SDLC, is fully validated and 21 CFR Part 11 compliant and has been audited by numerous Sponsors and CROs

Triumph Research Intelligence Limited

The Bradfield Centre

Cambridge Science Park

Cambridge

CB4 0GA

United Kingdom

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