Clinical Researcher—August 2026 (Volume 40, Issue 4)
SPECIAL FEATURE
Tejashree Kulkarni, MS
Clinical research has never been more digital, yet for research sites, the cumulative effect of the abundance of digital technologies now available can create a paradox: systems designed to improve efficiency may also introduce substantial administrative burden. This article examines technology fragmentation from a research site perspective and argues that the primary challenge is not digitalization itself, but the lack of integration and standardization across the clinical research ecosystem. Reducing unnecessary administrative burden will require greater interoperability, standardized access management, reduced duplication, and the inclusion of technology burden in study start-up and feasibility planning.
The Digitalization Paradox
As clinical research experiences digital transformation, processes that once relied heavily on paper files, e-mail correspondence, and manual documentation are now supported by electronic regulatory (eRegulatory) systems, electronic data capture (EDC) platforms, electronic trial master file (eTMF) systems, safety databases, learning management systems (LMSs), interactive response technologies (IRTs), laboratory portals, imaging platforms, and electronic patient-reported outcome (ePRO) systems. The benefits are clear—digital platforms can improve accessibility, facilitate remote collaboration, strengthen audit trails, support data quality, and increase visibility across geographically distributed teams.
However, the value of any individual system cannot be evaluated independently from the broader technology environment in which research sites operate. A single clinical trial may require site personnel to access multiple sponsor portals, contract research organization (CRO) systems, EDC platforms, safety reporting databases, training systems, IRTs, laboratory portals, imaging platforms, and document exchange systems. Each system may be reasonable when viewed independently; the operational challenge emerges when site personnel must use all of them simultaneously.
This phenomenon can be described as “death by a thousand portals.”
The phrase is not intended to suggest that any single portal is inherently problematic. Rather, it describes the cumulative effect of many small administrative demands: another login, another training module, another access request, another password reset, another document upload, and another system-specific workflow. Individually, these tasks may appear minor; collectively, they can become a significant operational workstream.
The Evidence: A Growing Technology Burden
The available evidence demonstrates that technology-related burden is not simply a perception.
The Advarra 2023 Study Activation Survey{1} found that:
- 55% of sites reported that set-up and training on sponsor-provided technology was extremely or very burdensome.
- 67% reported that this burden had increased compared to five years earlier.
- Nearly 70% reported managing six or more logins per study.
- 81% reported that using their own site credentials to access multiple systems would be valuable.
The survey also demonstrated the breadth of the technology ecosystem used in clinical research. Respondents reported widespread use of EDC, IRTs, safety letter distribution, ePRO and electronic clinical outcome assessment (eCOA) systems, LMSs, document exchange platforms, and site payment systems.{1}
A separate analysis published by the Association of Clinical Research Professionals reported that a typical investigator site worked with an average of 12 different systems to collect clinical research data. The analysis also reported that fewer than 10% of sites believed sponsor- and CRO-provided technology adequately met their operational needs.{2}
These datapoints should not be interpreted as evidence that technology is inherently harmful to clinical research. Instead, they highlight a more specific concern: the cumulative technology environment may be creating administrative requirements faster than the industry is eliminating them.
The Site-Level Reality
From the perspective of a research site, technology is experienced as a workflow rather than as a collection of individual products.
Site personnel may need to:
- request access to multiple systems through separate workflows;
- complete different training modules for similar functions;
- upload the same CV, license, or training certificate into multiple platforms;
- monitor multiple systems for notifications;
- maintain different usernames and passwords;
- complete recurring system certifications;
- contact different technical support teams for different platforms; and
- track access and training status across multiple studies.
The result is a form of administrative duplication.
A site may maintain a current investigator CV in its institutional systems. The same document may then need to be uploaded to several sponsors, CRO, or vendor platforms. A staff member may complete Good Clinical Practice (GCP) training through an institutional LMS, then complete additional sponsor-specific training, then complete separate training within another vendor platform. Each requirement may be justifiable from the perspective of the individual organization requesting it; from the site perspective, however, the work is cumulative. This distinction matters because the time required to access, learn, maintain, troubleshoot, and monitor technology is rarely visible in the traditional measures used to assess study complexity.
The Hidden Time Drain
Technology-related workload is often distributed across many small tasks. Because each task may take only a few minutes, the total burden can remain largely invisible.
Across studies, site personnel may spend time:
- completing duplicate or substantially similar training;
- requesting and following up on access approvals;
- managing password resets and account lockouts;
- uploading identical documents to different systems;
- monitoring system-specific notifications;
- maintaining separate records of access and completion;
- responding to vendor-specific technical questions; and
- repeating similar workflows across different sponsors and CROs.
These are not merely incidental activities. They require staff time, follow-up, technical support, and ongoing maintenance. Yet they are rarely included in feasibility assessments or explicitly reflected in study start-up planning. The cumulative burden is particularly significant because the same site personnel may be performing these activities across multiple active studies.
A coordinator may be required to manage several different training systems. A regulatory specialist may upload the same core documents repeatedly throughout the year. A study manager may spend significant time troubleshooting access issues across multiple platforms. The problem is therefore not simply the number of systems used by one study—it is the interaction between the number of systems used per study and the number of active studies managed by the site.
When Technology Becomes a Study Start-Up Dependency
Study start-ups are especially vulnerable to technology fragmentation.
Before a site can fully begin study activities, personnel may need to:
- receive invitations to multiple systems;
- create or activate accounts;
- complete required training;
- obtain role-specific approvals;
- complete system certifications; and
- resolve access or technical issues.
These activities may be managed by different sponsors, CROs, vendors, and support teams.
The Society for Clinical Research Sites has identified multiple login credentials, nonstandardized access processes, multiple support teams, and numerous handoffs as challenges associated with clinical trial system access. These challenges may contribute to poor user experience, study startup delays, and operational inefficiencies.{3} This creates a potential mismatch between the clinical trial’s formal start-up timeline and the site’s operational readiness.
A site may have completed its regulatory, contractual, budgetary, and training requirements, while individual staff members remain unable to perform study activities because they are still waiting for access to one or more required systems.
This raises an important question:
Should technology access and training be treated as minor administrative tasks, or should they be recognized as measurable study start-up dependencies?
The evidence suggests that the latter approach deserves greater consideration.
The Core Misalignment
The challenge is not technology itself; the challenge is that each stakeholder often selects systems based primarily on its own operational requirements. Sponsors may select systems that support sponsor oversight. CROs may use systems that support centralized trial management. Vendors may provide platforms optimized for specific services. Sites, however, must operate across all of these systems simultaneously. The site therefore experiences the cumulative effect of decisions made by multiple stakeholders.
This creates a structural misalignment:
Each individual system may be optimized for a specific function, while the overall technology ecosystem may not be optimized for the people required to use all of the systems together.
From a site perspective, technology is not experienced as a series of independent products—it is experienced as a workflow. When a coordinator must move between multiple systems to complete one operational task, the site experiences the entire process, not the individual system.
Interoperability Should be Measured by Human Effort
Interoperability is often discussed as a technical objective; however, in clinical research, it is also an operational objective. When systems cannot exchange information, site personnel may be required to perform the connection manually.
This may involve:
- re-entering data;
- uploading the same document multiple times;
- manually reconciling information;
- monitoring multiple systems for changes; and
- maintaining separate records across disconnected workflows.
A system may technically exchange data with another system and still require substantial manual intervention. Therefore, interoperability should be evaluated not only by whether systems can communicate with one another, but also by whether that communication reduces the amount of repetitive work required from the humans operating between them. This is an important distinction.
The goal of interoperability should not simply be data exchange.
The goal should be reduced by human friction.
Measuring Technology Burden
Clinical research technology is commonly evaluated based on functionality, security, compliance, data quality, cost, and user adoption. These measures are important; however, technology should also be evaluated based on the administrative burden it creates for the people required to use it.
Potential measures could include:
| Domain | Potential Measure |
| Access | Number of systems requiring individual user access |
| Credentials | Number of logins required per staff member |
| Training | Number of mandatory technology training modules |
| Documents | Number of platforms requiring duplicate uploads |
| Support | Number of separate technical support channels |
| Workflow | Number of manual transfers between systems |
| Maintenance | Number of recurring certifications |
| Time | Estimated staff hours required for technology onboarding |
Such measures could allow technology-related workload to become visible during feasibility and study start-up.
Sponsors and CROs could ask:
- How many systems will this study require?
- How many staff members will require access?
- How many hours of technology training are expected?
- How many systems require recurring certification?
- How many documents will need to be uploaded repeatedly?
- What is the expected time to complete system onboarding?
- What support will be available when access problems occur?
These questions would help shift the conversation from “Does the site have access to the required technology?” to “What is the total operational burden of the technology required by this study?”
Practical Opportunities for Reducing Site Burden
The solution does not necessarily require eliminating specialized systems. Rather, the industry should focus on reducing unnecessary friction.
Standardized Access Where Possible
Single sign-on, federated identity management, and standardized site credentials may reduce the number of credentials that staff must manage. The Advarra survey found that 81% of respondents considered using their own site credentials to access multiple systems valuable.{1}
Reduce Duplicate Training
Training requirements should distinguish between protocol-specific, safety-critical, role-specific, and system-specific training. Where appropriate, completed training should be recognized rather than repeatedly assigned.
Reduce Duplicate Document Submission
Sponsors, CROs, and vendors should explore ways to reuse verified information rather than repeatedly requesting the same documents.
Improve Interoperability
Open application programming interfaces, standardized data structures, deep linking, and automated data exchange may reduce manual duplication.
Include Technology Burden in Feasibility
Feasibility assessments should consider the number of systems, logins, training requirements, access approvals, and recurring certifications required for the study.
Treat Technology Access as a Start-Up Milestone
System access should be incorporated into study start-up planning as an operational milestone rather than treated as an informal administrative task.
Design for the Site Experience
Technology should be evaluated from the perspective of the people who use multiple systems every day. A platform that works well for a sponsor or vendor may still create significant burden for the site.
The relevant question should be:
What is the total workflow required to complete the task across the entire clinical research ecosystem?
A Shared Responsibility
Reducing technology fragmentation cannot be the responsibility of research sites alone. Sites generally do not select most sponsor-required systems—they are often the recipients of technology decisions made elsewhere in the clinical research ecosystem. Sponsors, CROs, vendors, technology providers, and sites must therefore share responsibility for reducing unnecessary burden. Sponsors and CROs can evaluate the cumulative technology requirements of a study before implementation. Technology providers can prioritize interoperability and open integration.
Sites can communicate the operational impact of system requirements. Industry organizations can develop common standards for access, training, credentials, and data exchange. The goal should not be to create one system for every clinical trial. The goal should be to create an ecosystem in which the number of systems does not automatically determine the amount of administrative work required from site personnel.
Conclusion
As noted earlier, clinical research has never been more digital; however, digital transformation does not automatically equal operational transformation. The available evidence demonstrates that research sites are managing substantial technology-related burden and supports a broader concern: clinical research technology is often implemented as a collection of disconnected solutions rather than as a connected ecosystem. The result is a growing collection of portals, credentials, training modules, access workflows, notifications, and duplicated administrative tasks. The problem is not that clinical research has too much technology. The problem is that technology is too often designed as a series of individual solutions rather than as a connected workflow.
Technology should reduce friction in clinical research, not redistribute friction to the people conducting it. If every new study adds another portal, another login, another training requirement, and another administrative workflow, the cumulative burden eventually becomes impossible to ignore. Research sites are not struggling with one system—they are managing the accumulation of many systems. The next phase of digital transformation in clinical research should therefore be measured not only by how much technology the industry adopts, but by how much unnecessary work that technology eliminates.
References
- Advarra. 2023. New clinical trial industry survey reveals increased burdens on sites. https://www.advarra.com/news/new-clinical-trial-industry-survey-reveals-increased-burdens-on-sites/
- Carozza D. 2020. Tool or bludgeon: Technology can support clinical trial sites or undermine them. How are you using it? Clinical Researcher 34(3). https://acrpnet.org/2020/03/10/tool-or-bludgeon-technology-can-support-clinical-trial-sites-or-undermine-them-how-are-you-using-it
- Society for Clinical Research Sites. Accelerating study startup. https://myscrs.org/resources/accelerating-study-startup/
- Society for Clinical Research Sites. Connecting the clinical ecosystem to alleviate site burden. https://myscrs.org/resources/connecting-clinical-ecosystem/
Tejashree Kulkarni, MS, is a Clinical Trial Manager with experience in site-level clinical research operations, including study start-up, feasibility, budgeting, regulatory compliance, and day-to-day trial conduct. Her experience spans coordination of multidisciplinary study teams and support of regulatory inspections and sponsor audits. She is focused on improving clinical trial quality and operational consistency through practical application of Good Clinical Practice principles.
