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Randomized clinical trials are the gold standard for collecting evidence-based data on the efficacy and safety of medical interventions. In the wake of the global COVID-19 crisis, sponsors of many ongoing and upcoming clinical trials were quickly pressured to leverage their use of technology to keep up with this new era of virtual studies. Although the transition of introducing digital solutions to clinical trial management has its challenges, its benefits for efficiency and saving resources can’t be overlooked. Here are five essential tools every sponsor, CRO, and site needs to ensure their clinical trial is a success.

1 | Maintaining Clinical Trial Files: Electronic Trial Master File (eTMF)

The future of clinical trials is paperless and this requires a robust platform that can easily maintain important documentation and provide clear records for review by regulatory agencies. eTMFs are in use by most sponsors and contract research organizations (CROs), including Vial CRO, but they must have certain features to maximize their usefulness in clinical trials. Your eTMF software should include a powerful search function, user access controls, full audit trails, a workflow for easy document management, and the ability to sign electronically. This tool also needs a strong notification system to make all stakeholders aware of any new changes. eTMF technology is an industry-standard because it allows for sponsors to streamline their management and organization of essential clinical trial files.

2 | Tracking Participants and Study Drug: Interactive Response Technology (IRT)

This technology acts as an accessible hub for tracking participants and investigational products (IP) in a clinical trial. The best IRT platforms allow users to add or randomize subjects, update patient statuses (e.g., screen failure, lost to follow up, withdrawal of informed consent, etc.), and perform study IP management (e.g., shipment receipt, viewing kit assignments, dispensations, destructions, returns, etc.). Although IRT systems don’t store any medical or regulatory data, they’re critical for providing sites, sponsors, and CROs with a detailed overview of their patients and their products.