“Trial Interactive has become an industry leader, delivering a balance of powerful enterprise technology and supporting services (such as TMF management) that can meet the nuanced requirements for pharma, biotech, medical device makers, and CROs of all sizes.”
Phil Shawe, President and CEO of TransPerfect, has been spearheading the company’s growth with his keen focus on the success of each and every one of his more than 5,000 employees. Phil heavily promotes an “entrepreneur-in-residence” program, where employees are encouraged to create their own concepts and strategies and then actually build their business within TransPerfect’s business. From this very program emerged the TransPerfect Life Sciences division and their e-clinical platform, Trial Interactive.
In 2007, after 15 years of experience working with life sciences organizations, Trial Interactive helped lead the paperless revolution by introducing their eTMF solution to the market. Internal subject-matter experts saw firsthand the administrative challenges faced by global study teams across the clinical lifecycle, from site selection all the way through study archival. The Trial Interactive E-Clinical Innovation Team emerged to help sponsors reduce compliance risks and administrative costs while expediting timelines and, ultimately, time to market.
An end-to-end approach to clinical document processes and inspection readiness is difficult for organizations to achieve without practical, configurable technology and, very often, additional expertise and resources to establish best practices and scale document management to prepare for regulatory scrutiny.
Trial Interactive has become an industry leader, delivering a balance of powerful enterprise technology and supporting services (such as TMF management) that can meet the nuanced requirements for pharma, biotech, medical device makers, and CROs of all sizes. Now a complete clinical document collaboration experience, Trial Interactive ensures a seamless workflow across all phases to resolve challenges of speed, quality, completeness, and inspection readiness. Documents can be authored, reviewed, approved, and submitted for approvals or indexed in the eTMF all within a single environment.
Trial Interactive has many success stories in their 10+ years of innovation of helping organizations of all sizes with their TMF needs, but smaller organizations, in particular, are often in need of supplementary support. A recent example outlines an engagement with a life sciences sponsor who faced a history of quality issues and problems with inspection readiness.
Challenge
- Migrate seven ongoing phase 1 and 2 studies to an eTMF and support archiving for 25 years per study, per EU compliance.
- Three historical studies—all on paper—in need of reconciliation, QC, and coding for over 10,000 pages and 1,300 documents.
- Three active studies in need of coding and QC.
Solution
Trial Interactive had the sponsor up and running on TransPerfect’s eTMF—aligned with the TMF Reference Model— in less than 30 days. All of their past and present studies were now centralized to manage active studies and archive historical studies within the same platform. TransPerfect’s global operations and document processing teams enabled them to easily and securely transport documents for processing.
- All studies were actively migrated to the eTMF, making it easy to archive and comply with the 25-year standard.
- For the three historical studies, documents were reconciled, QCed, processed and archived in two-month sprints.
- The three active studies in need of coding and QC were brought up to speed within two months.
Looking ahead, Trial Interactive will roll out a clinical trial management system (CTMS) offering in 2020 that will enable study teams to have a single, central view of all processes across the clinical lifecycle. This development will provide study teams with a flexible oversight solution that offers the data views needed to see the story of the entire collaborative effort. Along with the CTMS, Trial Interactive will continue to make clinical processes more intuitive and automated and insights more predictive through platform enhancements and machine learning.
