Hungary-based speciality pharmaceutical company Gedeon Richter has partnered with TransPerfect Life Sciences to use its Trial Interactive solutions in upcoming clinical trials.
The integration of TransPerfect’s electronic trial master file (eTMF) platform and TI Collaborate e-clinical solution is intended to enhance the efficiency and quality of the trial processes by streamlining TMF operations.
The Trial Interactive eClinical platform was designed by clinical professionals and is employed by biotechnology, pharmaceutical, medical device and contract research companies.
It aims to help simplify product development life cycles within a reliable 21 CFR Part 11-compliant environment.
The AI-enhanced platform is designed to expedite and improve processes across site selection and identification, personnel training, trial start-up and the activation of sites, as well as eTMF management and closeout.
The comprehensive suite of products on the Trial Interactive platform is tailored for clinical research, aiming to streamline oversight, tasks and compliance while helping clients execute audits and inspections.
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By GlobalDataThe partnership is in line with Gedeon Richter’s focus on the development and manufacture of medications across various therapeutic areas, including women’s healthcare, neuropsychiatry, rheumatology, osteoporosis, cardiology, blood disorders, diabetes and the central nervous system.
Gedeon Richter global clinical operations head Balázs Szatmári said: “The Trial Interactive eTMF will help us streamline our TMF operations and maintain inspection readiness.
“We want to make sure our future studies have the same efficiency and more, which is why we’re excited to have their eTMF solution integrated into our clinical operations ecosystem.”
TransPerfect Life Sciences Trial Interactive division president Michael Smyth said: “We’re proud to be part of Gedeon Richter’s plans for new studies and look forward to working more closely with their clinical operations teams through our TMF services.”
In February 2023, US-based biotechnology company Surrozen began using the Trial Interactive eClinical platform to create a comprehensive TMF management approach.