echnology is awesome … until it isn’t, at which point, it’s downright exasperating.

This technology paradox is particularly true in clinical research today, especially for sites that have experienced both the benefits and the burdens of increasing numbers of disconnected systems. In a recent Study Activation Survey Report, sites report setup and training on sponsor-provided systems to be the most burdensome activity they face, even more than contracting and budgeting, which are historically considered the most arduous aspects of study start up. In fact, two-thirds of sites say the technology burdens are greater now compared to just five years ago.

“Modern technology has certainly improved clinical trial efficiency,” said Tina Bowdish, director of Cancer Research Network Development and Clinical Integration at AdventHealth—one of the premier faith-based, not-for-profit health systems in the US. “Additionally, some solutions enable staff to work from home, remote monitoring, and telehealth. These technologies decrease the financial burden on sites and enable more room at the site for patient-facing staff. Plus, they reduce burden on patients, which can accelerate enrollment and increase retention. On the other hand, it can go too far, causing technology overload for sites. Every sponsor, CRO, and vendor have their own system. At worst, these systems are standalone; at best, they may talk to some other systems.”

The clinical research industry has seen a surge of technologies that have helped make trials more patient-focused and accessible and, in many ways, more operationally efficient. However, the sharp increase in technology has also contributed to greater trial complexity. With sponsor-provided and site-owned technologies piling up, the current clinical model is reaching a breaking point. Tufts Center for the Study of Drug Development reports a staggering 70% of global site staff say trials have become more challenging to manage due to increasing complexity.

At the same time, trial sponsors and contract research organizations (CROs) are frustrated by slower trials. Complexity—in part caused by an abundance of disconnected technology—drove a 39% jump in trial timelines from 2008 to 2019, as delays of four to six months resulted in an estimated $100+ million lost over the life of a product.

Ironically, technology may actually be the cure for what ails clinical sites.

Connected Technology, not More Technology

In the 2024 Advarra Site-Sponsor-CRO Collaboration Survey, 46% of sites and 53% of sponsors/CROs agreed that improved systems and technology would enhance their relationships, but only 29% of sites felt that current technology solutions deliver on their promises of integration and efficiency.

Sites, for example, report that they must copy or transcribe data between systems about 60% of the time, and the same percentage say they frequently enter identical data into multiple systems. Duplicative work trickles through all aspects of the data management pathway, causing increased work for sites, CROs, and sponsors and slowing trials down.

“Implementing or updating technology almost always has a financial impact, and data security across all these different systems is another concern,” added Bowdish. “If it’s overused, technology can actually create a barrier between the site and the patient while creating unnecessary inefficiencies for sites.”

The challenge isn’t necessarily the number of systems but their lack of integration. Sites often must manage different platforms for training, investigational product accountability, electronic regulatory documents, data capture, patient assessments, and more — and they vary across trials, even across the same sponsor, while most of them are disconnected from each other. Fortunately, there are some ways sponsors and technology providers can help.

Streamline Logins on the Path to Integration

The unintended consequence of system proliferation is the high number of different logins and passwords for site staff to manage. Today, sites typically have six or more different logins per study for all the systems they use to conduct trial tasks—and many have much more with the increased use of decentralized and wearable technologies. Logins increase with the complexity of a trial, with a typical oncology study requiring the site’s own systems plus as many as 17 additional systems. Yet according to the 2024 Advarra survey, only 32% of sites say they can use their own system credentials when using these sponsor/CRO technologies.

Bowdish agreed. “Every study utilizes multiple systems—each with their own log-in information. This is incredibly inefficient and a huge burden on site staff.”

“All of the logins take time—five minutes here, five minutes there. It doesn’t seem like a lot, but it adds up quickly especially when we have to email someone to get access for a new staffer,” said Erin Williams, Senior Vice President of Study Startup for Velocity Clinical Research, a leading integrated site organization. “Imagine what we could do if we could take that time and replace it with a single login to a centralized, one-stop-shop system where all stakeholders could go to find all documents. It would dramatically reduce study start-up timelines and make an impact on the patient experience.”

One anonymous site respondent in Advarra’s 2024 survey said, “There are too many portals and systems requiring unique user IDs, passwords, and two-factor authentication for dozens of staff….it is a nightmare to try to maintain consistency in operations, and a double nightmare to try to train new staff.”

One solution is to enable Single Sign On (SSO) to all technologies—site practice systems, site research applications, and sponsor-provided tools—using sites’ own set of login credentials. More than 80% of respondents to an Advarra site survey said that being able to use their own site credentials to log in to sponsor-provided systems was “extremely” or “very valuable.”

SSO frees site staff from managing and juggling dozens of passwords and increases focus on participant qualification and enrolled participant engagement. It also improves security by eliminating the need for maintaining a centralized spreadsheet tracker that would provide a threat actor with access to credentials to all site systems in a single location. Further, SSO enables the automated propagation of employee account deactivation across all site and sponsor systems used on a study at exit.

Connect Systems While Preserving Site Choice

Certainly, one way to streamline the technology burden is for sponsors, CROs, and sites to standardize on a single technology stack. The problem is that the needs and experience of an academic medical center, hospital system, or private site are different. There’s no one-size-fits-all-sites solution. Sites want the ability to pick solutions that are best tailored to their unique needs, people, processes, and procedures.

The better option is for sponsors to offer a flexible ecosystem that both supports technology-naïve sites and enables choice for technology-enabled sites, but with connectivity to allow a frictionless flow of workflows, data, and documents without logging in and out of different systems. Seamless integrations between systems that sites prefer and may already be using versus sponsor-mandated systems that can vary from trial to trial will simplify site work for sponsors and non-industry-funded studies.

Ideally, sites can perform an activity once and flow it through every system—from a site’s electronic regulatory (eReg) binder system to a sponsor’s document exchange technology or from an Institutional Review Board (IRB) committee back to a sponsor’s electronic Trial Management File (eTMF) and a site’s eReg system. Rather than adding more standalone solutions, organizations should focus on connecting the ecosystem and integrating existing systems and ensuring data flows seamlessly between platforms to reduce human error, automate repetitive tasks, and streamline workflows. Overwhelmingly, sites (84%) and sponsors/CROs (86%) say a centralized, connected platform would prove valuable.

Integrated technology solutions that connect site-owned systems with sponsor-provided platforms can also minimize duplicate work and streamline document management—especially when connected to IRB review systems, which can further accelerate study start up.

“To improve collaboration, we need interoperability of IT systems within a site’s tech stack and with sponsor/CRO systems,” said Mark King, Vice President of Research & Innovation at Novant Health, an integrated site network of more than 900 locations and 19 hospitals serving the Carolinas. “Collectively, we spend an absurd amount of time manually creating pipes to connect systems. Our systems are replete with redundant manual data (re)entry—for instance, consider the study title alone. How many times will that be typed into multiple systems? Twelve, 20 times? Let’s create a solution where the simple NCT number from clinicaltrials.gov populates all these systems automatically.”

A connected clinical ecosystem not only improves speed and compliance, but also enables transparency—in the form of helpful tools, including status dashboards with alerts and notifications for outstanding actions and due dates. Sponsors can request a document, assign training, distribute a safety letter, or assign an activity due date—and the site is automatically notified and can track progress on a dashboard. At the same time, sponsors can track site status at the individual site, region, and global level on their connected dashboards to more efficiently manage activity.

Sponsors can provide even more value to sites by offering site engagement tools, such as visit calculators, guided activation workflows, and on-demand training videos specific to the visit being conducted. Patient engagement tools including recruitment trackers can also enhance the site-patient relationship. When all these technologies are integrated in the same connective ecosystem, sites, sponsors, and patients benefit through a single user experience.

“A single, centralized solution where teams could access all study start-up documents, processes, workflows including feasibility, contracts, and budgets, would be invaluable,” added Williams. “Ultimately, it would dramatically reduce confusion around portals and logins and provide streamlined access to everything sites need in one place including training, regulatory documents, patient enrollment information, and more. I can quickly provide access when needed. I can make sure people are trained. I can complete forms. It would allow us to push through study start up, slashing timelines.”

Connecting the clinical trial ecosystem while simultaneously giving sites technology choice is key to reducing friction that is pervasive throughout study start up and can alleviate unnecessary burden on sites. This demands interoperability between site and sponsor systems. A connected clinical trial ecosystem will provide sponsors, CROs, and sites transparency and easier access to information across various platforms, automate workflows to accelerate research and reduce inefficiency, and streamline document exchange to help ensure compliance and audit-readiness.

The Cure for What Ails Sites: Connected Technology

Overcoming these barriers will be critical in 2025, as clinical trials continue to become more complex with new regulatory requirements and as stakeholders change or add new technology systems to generate and capture data and trials become more global with the increasing number of sites being used across China, Japan, South Korea, and India.

The industry is paving the path to a new model that integrates technology into a connected clinical ecosystem. It is only through this path that the clinical research industry can realize all the promised technology benefits of acceleration, compliance, and transparency, while at the same time giving sites the freedom to define their own processes and workflow with their technology of choice.