In Focus: The Top Needs in a Clinical Trials Software Package
Examining those technology-supported areas that sponsors, CROs, and sites consider the most valuable.
Not sure of the features you want included in the clinical trial software purchases you plan to make in 2025? Perhaps it will help to take a look at the just published Florence Healthcare study1, which reports on those techno-supported areas that sponsors consider to be the most valuable to them, and also what clinical sites are thinking about as well. While there are 4,320 or so contract research organizations (CROs) in this country alone, the field is dominated by a handful or two. Perhaps knowing what a sponsor wants on-site can help land that next trial contract opportunity.
And, just to make things more interesting, this article also will look at software features that buyers have listed as important.
Florence has been issuing its State of Technology Enabled Clinical Trials Report for five years now, so there is contextual data available for comparison. The latest survey included more than 100 sponsors, CROs, and sites from 27 countries; those who responded were clinical research associates and coordinators and regulatory analysts.
The salient points of the Florence study:
Half the sponsors report that they are using artificial intelligence (AI) in some capacity, be it data collection and extraction, its analysis, or patient engagement—this last one listed only by one-quarter of the sponsors. The sites’ take on AI is all together different. Seventeen percent are using AI for data collection and extraction, and about 30% of the sites are just testing AI for data analysis and patient engagement uses.
The sites seem a bit reluctant to go all-in for technology. Nearly half are using eConsent, up from 29% in 2021. Esource gets some use, 58% last year vs. 22% in 2021. And 41% are using patient engagement technology; none reported using it in 2021.
To underscore the use of technology overall by investigative sites, 74% of them still record source data on paper, and 16% send shipments via postage; no sponsors or CROs reported using paper to mail information. Fifty-seven percent of the sites send documents via email, while 33% of the sponsors, besides using email, also use software such SharePoint. Just about 38% of the sites use electronic health record systems and eSource platforms.
What sponsors and site workers seem to agree on is using an electronic investigator site file (eISF), that soup-to-nuts collection of trial-site information as required by regulators. In 2021, 12% of sponsors said they were using an eISF. By this latest survey, 69% were doing so. The sites’ response difference wasn’t as dramatic: 45% in 2021 vs. 71% in 2024. An interesting data point difference turned up when the participants were asked if having compliance software was the first priority: 76%, sponsors; 82%, the sites. Another relatively close response: 75% of the sponsors said they use one to five systems per study while 71% of sites said the same thing.
Seventy-seven percent of the sites reported they want to use their own platforms. Very few sponsors, 17%, are providing dedicated portals to their clinical trial sites, and only 37% of those sites are actually using those dedicated portals. The differences between the two groups regarding “yours vs. mine” are more acute between the 20242 and 2023 Florence studies. The sites’ demand for remote document and information exchange decreased, 13.87% in 2023 to 5.83% in 2024. Site investment in feasibility platforms increased to 43.88% in 2024 from 22.54% in 2020.
It isn’t surprising, therefore, that both groups identified the following as their biggest hurdles: integration and connectivity with existing platforms, 58%; issues with budget constraints, 58%; and training and implementation, 50%.
As for those software features that buyers consider important when looking for clinical research management systems, Capterra, a company that advises other organizations on their software needs, compiled a collection of products from its clinical trial software directory and sorted them according to customer reviews.3 The highlighted features were “based on their relevance and the percentage of products in Capterra’s directory that offer them.”
Of the approximately 25 systems on the first of 10 pages, 19 had these three: 21 CFS Part 11 compliance, audit trail, and data capture and transfer; 16 of those 19 also included data import/export, document management, and electronic data capture as priorities. Every product on this page, on the other hand, included HIPAA compliance and workflow management as highlighted features. And most had patient monitoring.
Christine Bahls is a Freelance Writer for Medical, Clinical Trials, and Pharma Information
References
1. 2025 State of Technology Enabled Clinical Trials. Florence. https://learn.florencehc.com/hubfs/1-florence/reports/RP-2025-State-of-Technology-Enabled-Clinical-Trials-Report-TOFU.pdf
2. 2024 State of Tech-Enabled Clinical Trials Report. Florence. https://23578418.fs1.hubspotusercontent-na1.net/hubfs/23578418/1-florence/reports/RP-2024-State-of-Tech-Enabled-Clinical-Trials-Report-TOFU.pdf
3. Clinical Trial Management Software. Capterra. https://www.capterra.com/clinical-trial-management-software/#buyers-guide-content
What Can ClinOps Learn from Pre-Clinical?
August 10th 2021Dr. Hanne Bak, Senior Vice President of Preclinical Manufacturing and Process Development at Regeneron speaks about her role at the company as well as their work with monoclonal antibodies, the regulatory side of manufacturing, and more.
