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.
3 | Gathering and Storing Clinical Visit Data: Electronic Source (eSource) and Data Capture (EDC)
These are essential tools needed for a successful clinical trial because they allow the study team to store and review valuable patient data. Traditional RCTs require sites to record visit information on paper source documents, before transcribing it into an EDC platform. However, this not only results in inefficient double data entry by site staff but the study team is also limited to conducting time-consuming on-site monitoring visits. Forward-thinking companies, like Vial, recognize the need for improvement here and have now developed their own technology. With Vial’s user-friendly eSource platform, sites enter clinical visit data only once because of its direct integration with the Vial EDC. Sponsors can then see the input in real-time, which allows for easier remote source data verification. These technologies enable clinical trial management to become more sustainable and effective because they save companies time and money in the long run.
4 | Collecting Patient Data: Electronic Patient Reported Outcomes (ePRO)
In every clinical trial, the quality of outcome data reported by patients will be a critical factor in determining whether that study drug can successfully reach approval. A reliable ePRO tool must make questionnaire completion into a simple, intuitive task with user-friendly technology, otherwise, data integrity may be impacted by patient non-compliance. The Vial ePRO solution is designed to minimize subject burdens with its well-configured questionnaires and automated notification system. Its integration directly into Vial EDC also allows for direct crosstalk between platforms, saving sites the need for additional data input.
5 | Finding and Managing Potential Participants: Virtual Recruitment Tools
One of the top concerns for clinical operations teams is the challenge of patient recruitment, which delays nearly 80% of all clinical trials. The development and use of technology to aid study enrollment is steadily increasing. To find potentially eligible subjects, sponsors should take advantage of digital tools such as algorithms for electronic health record (EMR) mining, social media, well-trained pre-screening call centers, and more. The inclusion of these aids can help spread clinical trial information to a more diverse group of patients, while minimizing overreliance on a site’s own local population.
Although healthcare technology has recently seen massive advances, clinical trials have been slower to adopt them into practice. With the use of digital tools to enable easy file management, streamlined data collection, and greater patient recruitment, sponsors can equip their studies to be better prepared to take a drug to market. Vial is committed to today’s new era of paperless clinical research with their innovative tech-enabled services. Visit https://vial.com/cro/ to learn how our tools are delivering superior clinical trial outcomes.