From creating matchless user experiences or the latest in web and application development to regulated health and safety systems, document management, database integration, and best practices consulting, expert technical staff at Technical Resources International, Inc. (TRI) will ensure that you have all the information and tools you require to be successful. Our intimate knowledge of the biopharmaceutical development process saves you time and money and sets us apart from other service providers.
- Systems Integration
- Clinical Data Management Systems
TRI provides full system support for the leading CDMS tools, with specialized expertise in Medidata Rave, Oracle Clinical and OpenClinica platforms for validated remote data capture.
- Pharmacovigilance and Drug Safety Systems
We support Oracle Argus Enterprise and comprehensive PVG features using the Empirica platform for signal detection and analysis.
- Document and Content Management (eTMF)
Core document management expertise on Microsoft SharePoint 2013 and 2016 as well as certified experts in Office365 and SharePoint Onlnie, Open Text ECM and LiveLink, Documentum 6.5, and SpringCM. Validated Regulatory Content Management in Veeva and Mastercontrol eTMF platforms.
- Regulatory Publishing and Submission
We have integrated Extedo eCTD publishing software with our Veeva platform, and also deployed LIQUENT InSight to support the submissions of over 6,000 IND submission per year.
- Clinical Management Portals and Collaboration
Trials generate a great mass of information. TRI combines expertise in content management, web development and clinical trials to deliver clinical trial information into a single platform so all study staff have access to documents, metrics, events, and announcements.
- Visual Analytics
- TRI’s custom Spotfire or SAS-based Business Intelligence (BI) solutions provide targeted analytics to address specific customer concerns.
- Vendor SaaS platforms including Empirica Topics, Signal and Veeva eTMF tools gives immediate access to trial data and metrics for our clients using TRI Clinical and Safety solutions.
- Custom Applications Development
- Our primary areas of expertise are Architecture Review, Installation Support, Mentoring, Code Review, Tuning and Agile Development procedures for:
- SharePoint 2013, 2016, & SharePoint Online
- ASP.NET 4.5 and .NET Core development
- Clinical Data transport and security solutions
- Oracle 11g and Microsoft SQLServer Development
- Validation of Regulated Clinical Systems
- Core validation services focus on 21 CFR Part 11 compliance but extend to provide clients with confidence in the integrity and accessibility of their web-based systems with additional checks for:
- Accessibility (Section 508, WCAG 1 and 2)
- Legal Compliance (US, CAN-SPAM, GDPR, Trademark and Copyright)
- Search Optimization for Public Systems
- Standards Compliance (W3C HTML/XHTML & CSS)
- Clinical Systems Best Practices Consulting
- Our staff ensures that the architecture, code, and system are properly designed, built, and documented.
Based on our international work, TRI’s project teams are especially knowledgeable about developing countries’ regulations and cultural differences, and have developed effective remote (also called central) monitoring procedures and tools. At any given time, TRI CRAs monitor more than 75 studies and review more than 1500 regulatory documents per month. To meet our clients’ needs, we provide our clinical operations services individually or as part of a package.