The Reality of Long-Term System Integrations in Life Sciences
In clinical life sciences IT, system integration is rarely a one-time achievement. It is a long-term commitment with real operational and human consequences.
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Streamlining clinical trials with Trial Interactive eTMF-enhancing efficiency, slashing costs, and integrating seamlessly for optimal results.
SCOPE International is a leading full-service contract research organization (CRO) with 24 years of international clinical research experience. Headquartered in Mannheim, Germany, and with 14 locations across Europe, SCOPE leverages its extensive experience managing major trials and post-market analysis studies to offer comprehensive clinical development and consulting services to the pharmaceutical, biotechnology, and medical device industries.
In 2018, SCOPE was looking for an innovative technology to streamline TMF management and enhance its document management processes. SCOPE needed a flexible partner to speed up processes in study setup and integrate seamlessly with its incumbent clinical trial management system (CTMS), InSIGHT, to facilitate document transfer to the eTMF.
Initially selected in 2018, TransPerfect’s Trial Interactive has become the preferred eTMF partner for SCOPE’s clinical trials in all major indications across phases I–IV. With continuous platform innovation and feature updates, SCOPE felt confident scaling with the platform for new studies.
The partnership between TransPerfect and SCOPE is providing significant advantages to sponsors, including quicker setup times for new trials, reduced initial costs, and more efficient file management through an application programming interface (API). These improvements have not only ensured the timely management of Trial Master Files (TMF) but have also optimized budgets for TMF maintenance, demonstrating a commitment to leveraging innovative solutions for more cost-efficient and effective clinical trial management.
The Reality of Long-Term System Integrations in Life Sciences
In clinical life sciences IT, system integration is rarely a one-time achievement. It is a long-term commitment with real operational and human consequences.
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Ask an Expert Office Hours - ICH E6(R3)
ICH E6(R3) is reshaping how sponsors and trial teams think about oversight, quality, and evidence in the Trial Master File. While the principles are clear, applying them in real TMF operations often raises practical questions.