Investigative Site Investment, Preparedness, and Experience with Digital Solutions

Much has been written about investigative site challenges with clinical trial technologies, particularly those supporting decentralized clinical trial (DCT) models. Over the past several years, the dominant narrative has suggested that clinical sites feel both overburdened by and resistant to the expanding use of digital tools in study design. Sites recognize the potential operating efficiencies to be gained, and the benefits to patients achieved, by using digital tools, but what many sites report struggling with are the fragmented and poorly coordinated number of solutions required by sponsors and contract research organizations (CROs).

Moreover, a growing number of investigative sites have invested in their own validated technology solutions, some that are well-integrated into their health system’s electronic health records and clinical practices. Yet many sponsors and CROs have limited familiarity with these site capabilities. Initiatives such as the Site Readiness Practices Framework for Decentralized Trials and Bring Your Own Technology (BYOT) Playbook are helping sponsors better assess site preparedness and technology capabilities.

To add to these efforts to inform industry understanding of investigative site preparedness and experience with remote and virtual solutions, the Tufts Center for the Study of Drug Development (CSDD) recently conducted a global survey of investigative sites. The aims of the study were to assess when, where and why investigative sites have invested in virtual and remote solutions supporting patient visit convenience and data collection and the primary value proposition that these solutions offer.

Assessing the value proposition

The study was conducted in collaboration with, and support from, Evinova, a separate health-tech business within the AstraZeneca group delivering digital solutions to accelerate clinical development. Tufts CSDD launched an online global survey among investigative sites between April and May 2025. Invitations were emailed to approximately 5,000 investigative sites. Data cleaning and analysis were performed in RStudio. Tufts CSDD conducted descriptive statistics and subgroup analyses. Responses from a total of 387 investigative site professionals—representing approximately 275 distinct investigative sites—were analyzed. Table 1 presents the digital tools assessed as these are the primary digital solutions used by investigative sites.

Clinical and administrative personnel from a broad cross-section of mature (10+ years conducting clinical trials) global investigative sites completed the survey (see Table 2). Six out of ten sites operate in North America and 22% in Europe. Approximately half of respondents are based within an academic research setting; half within an independent community-based research setting. Most respondents (70%) reported having more than eleven years of experience at their current organization. Survey respondents reported having experience with a broad mix of therapeutic areas.

Site receptivity, preparedness and experience

More than three-out-of-four respondents reports having experience using digital solutions.This finding is consistent with other industry reports affirming that the deployment of digital solutions in clinical trials is becoming more commonplace. In addition, nearly all respondents (>93%) believe that solutions supporting remote patient monitoring and/or management are playing an essential role in ensuring patient adherence with the protocol; collecting quality-of-life information; and gathering biometric and physiological data. The majority of respondents (82%) perceive that study participants are ‘very’ or ‘somewhat’ receptive to the use of remote data collection and patient monitoring solutions.

Slightly more than one-third (36%) of respondents indicated that their site has made dedicated investments in digital solutions; 64% have not yet made an investment (see Figure 1). Nearly half of respondents (47%) indicated that the primary reason for making an investment was to support and expand their clinical research offerings and capabilities.About one-third of investigative sites indicated that the primary reason was to enhance clinical care (30%). Approximately one-out-of-four investigative sites (22%) reported that that their primary reason for investing in digital solutions was to improve operating efficiencies.

In addition to investments in operational-support systems such as clinical trial management systems, electronic regulatory and operating documentation and electronic data collection, the results of this study reveal that sites are investing in a much broader range of digital tools (see Table 3).

The most common digital data collection investments include eDiaries or clinical outcome assessments platforms (ePROs), medical devices including wearable devices for self-collection of biovital data, remote data collection and patient monitoring. The most common investments supporting remote site visits focus on operational and logistics convenience-enhancement services including telehealth or secure video visit technologies, eConsent systems, and patient payment solutions. A smaller relative percentage of sites report investing in local and home-based clinical services including local lab facilities used for specimen collection, home nursing visits and investigational medical treatments shipped directly to patients’ homes.

Most sites report making investments in digital solutions after the start of the global COVID-19 pandemic. Between 30% and 40% of sites, however, report making dedicated investments in digital solutions long before the pandemic. Figures 2 and 3 provide a more detailed look at when dedicated digital solution investments were made.

A higher percentage of investigative sites that conduct oncology trials (30%) reported investing in remote site visit tools compared with sites that do not conduct oncology trials (19%). In addition, a higher percentage of investigative sites conducting a larger relative annual volume of clinical trials (32%) reported making dedicated investments in digital solutions compared with smaller annual clinical trial volume sites (20%).

Increasing the quality and accuracy of the data collected was most frequently mentioned as a top benefit of using digital solutions. Enabling faster access to data about the patient’s health status was the next most frequently mentioned benefit (see Table 4). A much smaller relative percentage of sites mentioned that increasing patient engagement and improving patient convenience were among the top three benefits.

Financial impact of digital tools

The majority of sites (64%) reports that the use of digital solutions has had no material financial impact (see Figure 4). Nearly one-out-of-four investigative sites (22%) reports that they have lost revenue and/or profitability as a result of using digital solutions and 14% report improving revenue and profitability through the deployment of such solutions.The top causes of revenue and profit loss include difficulty coordinating the technology, personnel time devoted to troubleshooting issues and training for personnel and patients.It should be noted that this question did not specifically differentiate between sponsor-provided systems and site-invested/owned solutions.

Closing thoughts

Nearly 40% of investigative sites believe in the value proposition of digital solutions, so much so that they have dedicated financial investments in a broad range of solutions above and beyond those provided by a sponsor for a given clinical trial. These results counter the common narrative that sites are resistant to using remote and virtual technologies.

It is well recognized that the latest global pandemic in 2020 necessitated the adoption and use of virtual and remote technologies. The results of this study suggest, however, that site investments in digital tools and technology began much earlier. Approximately one-third of sites made investments in these tools as much as two decades earlier to improve efficiency, reduce costs and enhance the quality and safety of patient care.

Several global trends help explain why investment in, and adoption of, select digital solutions are more widespread than expected. Necessitated in some cases by government requirements and operating needs, a growing number of healthcare providers around the world have deployed systems supporting electronic health records (EHR). Healthcare providers also offered technology solutions—many integrated with their EHR systems—to improve convenience for patients and drive higher levels of adherence.Clinical sites, many based within healthcare systems, replicated and adapted use of these solutions in their clinical trial activity. The 2000’s also saw the rise of the “e-patient” as use of the internet became widespread.Equipped with online information, patients began taking a more active role in their healthcare and wanting to be more engaged in their health decisions.Telemedicine and remote patient monitoring also emerged to address resource limitations and reach underserved populations.

Although it is difficult to completely disassociate investments to support clinical care from those supporting clinical trial conduct, this study found that clinical research-related investments were the main focus. As such, investigative sites may be more receptive to accept little to no gain in revenue and profitability and some degree of disruption associated with deployment of various digital solutions as long as participant access, convenience and improved enrollment performance are achieved.

This study reveals that site capabilities with remote and virtual offerings are more extensive than previously anticipated and call for re-thinking site receptivity and preparedness to support digital solutions. Shifting the narrative that resistance relates to the value and benefit of digital solutions to deployment-related concerns may help address sites’ frustrations related to how these technologies and solutions are being implemented. Specifically, the integration and coordination of digital solutions with site operations enables more convenience and more positive experiences for study participants and supports real time monitoring. Digital solutions are not intended to replace or diminish the site-patient relationship. Recognizing that sites have made significant infrastructure investments on their own in the last 15 plus years, primarily to support clinical research execution, creates even more impetus for sponsors and CROs to support integration with existing site systems as advocated by some of the recent industry initiatives.

Ruby Madison Ford, Kenneth Getz, and Beth Harper*

Tufts Center for the Study of Development, Tufts University School of Medicine

*Corresponding author

References

• Society of Clinical Research Sites (SCRS) Research Report. 2019. Impact Assessment of eClinical Technologies and Industry Initiatives on Sites. Retrieved from: https://myscrs.org/learning-campus/white-papers/
• Rosa, C. et. al. Using digital technologies in clinical trials:current and future applications. Contemp Clin Trials. 2021 January: 100: 106219. Retrieved from: https://pubmed.ncbi.nlm.nih.gov/33212293/
• Properzi, F. and S. Sudip.Digital Adoption at Clinical Research Sites Still a Work in Progress. DIA Global Forum. April 2021. Retrieved from: https://globalforum.diaglobal.org/issue/april-2021/digital-adoption-at-clinical-research-sites-still-a-work-in-progress/
• ACRP DCT Survey Report.2022.Delivering on the Promise of Decentralized Trials:Unexpected Perspectives from Clinical Research Professionals. Retrieved from: https://acrpnet.org/delivering-on-the-promise-of-decentralized-trials-unexpected-perspectives-from-clinical-research-professionals
• Society of Clinical Research Sites (SCRS) Research Report. 2022. Site Perspectives on Decentralized Clinical Trials. Retrieved from: https://myscrs.org/learning-campus/white-papers/
• Cascade, E. and J. Wurdeman.Looking at Clinical Trial Technology Through a Site Lens. Clinical Researcher. February 2024 (Volume 38, Issue 1). Retrieved from: https://acrpnet.org/2024/02/16/looking-at-clinical-trial-technology-through-a-site-lens
• Florence State of Technology Enabled Clinical Trials Report 2024. Retrieved from: https://www.florencehc.com/downloads/2024-state-of-tech-enabled-clinical-trials-report/
• Senn, C.Technology at Clinical Sites:The Good, The Back, and What Sponsors Can Do To Turn It Around. January 2025. DIA Global Forum. Retrieved from: https://globalforum.diaglobal.org/issue/january-2025/technology-at-clinical-sites-the-good-the-bad-and-what-sponsors-can-do-to-turn-it-around/
• Tenaerts P, Hernandez AF, and Lipset C. Clinical trial site readiness for decentralized trials – fitting trials into today’s world. Journal of Clinical and Translational Science 8: e43, 1–4. doi: 10.1017/cts.2024.17.Retrieved from: https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science/article/clinical-trial-site-readiness-for-decentralized-trials-fitting-trials-into-todays-world/EF9D40A7F1E67E07DDD5A83594F62839
• Decentralized Trials and Research Alliance (DTRA): Bring Your Own Technology (BYOT) Playbook. 2025. Retrieved from: https://www.dtra.org/hubfs/Bring%20Your%20Own%20Technology%20(BYOT)%20Playbook%20-%20July%202025-2.pdf?hsLang=en
• Yeung AWK, Torkamani A, Butte AJ, Glicksberg BS, Schuller B, Rodriguez B, Ting DSW, Bates D, Schaden E, Peng H, Willschke H, van der Laak J, Car J, Rahimi K, Celi LA, Banach M, Kletecka-Pulker M, Kimberger O, Eils R, Islam SMS, Wong ST, Wong TY, Gao W, Brunak S, Atanasov AG. The promise of digital healthcare technologies. Front Public Health. 2023 Sep 26;11:1196596. doi: 10.3389/fpubh.2023.1196596. PMID: 37822534; PMCID: PMC10562722.
• Getz, K. Optimizing the Process for Adopting DCT Solutions. Applied Clinical Trials – 06-01-2023, Volume 32, Issue 6. Retrieved from: https://www.appliedclinicaltrialsonline.com/view/optimizing-the-process-for-adopting-dct-solutions