3 must have digital tools in clinical trials

There’s been a digital “fatigue” in the clinical research industry, and for valid reasons. During the COVID-19 pandemic as the vaccine trials picked up steam, many smaller sites and CROs were forced to adopt new digital tools. With the urgency of adoption, many didn’t take the time to evaluate against their strategic priorities. Now with pandemic in the rear sight, most of them question the practical usage and are dealing with the nuances brought due to such adoption. In my recent conversations with a mid-sized CRO based in California, the disparate data and workflow silos actually created more work than previously planned. The duplicate data and trackers created on multiple platforms added more work for the clinical team. Instead of replacing old ways of doing things, many kept on adding new tools, often doubling the work required for CRAs. Digital tools must be adopted with proper research in the first place, while clearly identifying the pain points being solved, with realization of RoI in the short-term. There are 3 absolutely must have tools that I have identified every CRO and site would want to have, to allow trial process efficiency.

Clinical Trial Management System (CTMS) : CTMS functions as the main collaboration hub for the research team. It’s not something new, but could make a huge difference in how the organization functions. Not all CTMS are equal in size, hence it is advisable to perform user requirements and weigh-in their priorities. An example is, some CTMS have recruitment and participant reimbursement modules that are suited for sites and may not be absolutely critical for CROs. Depending on the vendor and functionalities, the costs for CTMS could vary substantially. A good market research and performing due diligence with at least 10-15 separate vendors should provide a well rounded analysis of the varieties available to choose from.

Electronic Data Capture (EDC) : EDC system stores patient data collected in clinical trials. Many organizations are used to having multiple EDC systems. The benefits of using EDC are security of patient data, quick accessibility, regulatory compliance, accuracy and process efficiency.

Electronic Trial Master File (eTMF) : eTMF is a must have for every organization running clinical trial, where it acts as the “de facto” repository of all the documents related to the trial. The benefits of eTMF are similar to EDC, and mostly allow documents to be more secure, organized, and compliant with GCP. Most modern eTMF can be integrated with CTMS for tracking tasks and validating a single source of truth.?

Although this is not exhaustive, this should be a sufficient list for small to medium sites and CROs to remain organized and build a strong foundation for their digital transformation journey.