Building a Strong TMF: Compliance and Organization Essentials
Strong TMF management begins with the right foundation.
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TransPerfect Life Sciences: Supporting Clinical Research for 20+ Years
In the years before eTMF was even a word, we were there supporting clinical development and product commercialization efforts around the world. It was not very long ago when clinical processes were entirely on paper. Study teams needed options to reduce unnecessary challenges in the speed of operations, eliminating compliance risks, and the overall costs associated with administration, oversight, and paper-driven processes.
Breaking New Ground with Trial Interactive
As business process innovators with 60+ products across industries and global markets, we saw that the future of clinical operations was paperless and that process automation and real-time data insights would be keys to addressing these risk, time, and cost challenges for study teams around the world. In 2007, we launched what is now the Trial Interactive eClinical Innovation Team. This team of clinical and technology professionals worked directly with clinical operations leaders to develop a practical, clinical research-focused platform to streamline processes across the clinical lifecycle. This journey began with the Trial Interactive eTMF and emerged as an early influencer and leader in digitizing clinical operations. Now, the Trial Interactive platform has evolved to enable Pharma and Biotech Sponsors, and CROs to improve speed and quality in one seamless experience. Study teams can streamline processes across site identification, site selection, personnel training, study start-up, and site activation, through eTMF management and closeout As a 21 CFR Part 11 Compliant solution, Trial Interactive also provides users with a secure environment in which to capture and manage all required regulatory information to enable real-time inspection readiness.
Power, Practicality, and Accessibility for Organizations of all Sizes
Trial Interactive has been designed by clinical professionals, for clinical professionals with enterprise power to scale for any number of studies in organizations large and small. Often, due to cost of ownership, change management efforts, and complexity of implementation and adoption, small and mid-sized organizations can delay adopting technology that could revolutionize operations. Even worse, they may piece together seemingly cheaper and less purpose-fit technologies that ultimately create more administration and expense. Trial Interactive is an industry leader in delivering practical, flexible innovation complemented by a deep bench of clinical experts who can further assist in reducing risks through best practices or scaling your team with clinical personnel for support with critical document processes at any point in the study lifecycle.
eClinical Innovation is a Community Effort
The future of eClinical innovation is a collaborative effort. Our clients are not only Trial Interactive users, but members of our product team through our Customer Engagement Programs and direct access to product owners. We are proud to work with industry leaders to help bring life changing therapies to market by reducing compliance risks, shortening timelines, and lowering operational costs.
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The Three Pillars of Quality Management
Maintaining compliance, tracking documentation, and ensuring consistency across departments are key challenges for regulated industries. A comprehensive Quality Management System (QMS) streamlines documentation, training, and quality records management to support these needs.
Mastering Inspector Access: Streamlining Regulatory Reviews
Regulatory inspections can be complex and demanding, but a well-prepared Trial Master File (TMF) can significantly ease the process.