The Latest Advancements in Single Sign-On Technology

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Clinical research sites are overburdened by the growing complexity of trial protocols, difficulties enrolling representative participants, and increasing technological demands. 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.

The unintended consequence of system proliferation is the high number of different logins and passwords for site staff to manage. Logins also 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. Now consider the fact that most sites are managing multiple trials across different sponsors at the same time, which multiplies the number of systems and different logins exponentially.

“There are way too many portals and systems requiring unique user IDs, passwords, and two-factor authentication for dozens of staff,” said one site respondent to the 2024 Advarra Site-Sponsor-CRO Collaboration Survey which revealed that only 32% of sites say they can use their own system credentials when using these sponsor/CRO technologies. “It is a nightmare to try to maintain consistency in operations, and a double nightmare to try to train new staff.”

Erin Williams, senior vice president of study startup for Velocity Clinical Research, an integrated site organization, explained, “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,” she said. “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.”

SSO: How far have we come?

Single sign-on (SSO) was invented in the late 1980s as an identity and access management system to help companies and government agencies consolidate all their employees’ login credentials into a single infrastructure. The workforce was beginning to go digital, and employers quickly saw a problem when their workers started keeping track of their multiple passwords on post-in notes around their desks. Unfortunately, today’s sites are working under similar conditions as in the 1980s.

In healthcare, SSO started its road to mainstream adoption in the early 2020s at hospitals where physicians could use SSO solutions to make it easier for busy clinicians to log in to various applications while keeping networks secure. Pharmaceutical companies started adopting SSO around the same time but predominantly in commercial capacities to enable doctors to log in to their sites once, and access various data and information resources each associated with different drugs—yet there were early discussions of rudimentary forms of SSO in drug development in the 2010s.

While many modern-day versions of SSO allow site users to log in once, the problem is that most SSO platforms only allow users to access applications from a single technology provider or for a single trial. However, this approach doesn’t go far enough to alleviate site burden. Worse, it denies sites the flexibility to choose the systems that work best for their individual needs and prevents easy movement between systems from different sponsors and different trials.

This approach may be palatable for sponsors and contract research organizations (CROs), but it places unnecessary burden and limitations on sites. The cascading and compounding impact ultimately impacts patient care because resource-strained site staff do not have as much time to engage with participants. The industry should work to ease site burden by empowering sites to log in to all site systems (practice-management systems, research applications, and sponsor provided technology) using their own credentials—the same username and password that site staff already use to log in to their own internal systems. As an added benefit, such site-centric technology will help attract the best investigators and sites to conduct trials.

The next generation of SSO allows site staff to use their own credentials

More than 80% of respondents to the 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.’ Allowing sites to use their own credentials to log in to various systems fulfills the original promise of SSO. Some of these advantages include:

• Site Experience: By reducing the need to remember and manage multiple complex logins across different applications (aka password fatigue), site staff suffer fewer burdens with streamlined system access. This also allows site staff to focus more on caring for patients, which is typically their greatest motivation. By improving the site experience, too, sponsors can help make their trials more attractive amidst increased site competition.
• IT Cost Savings: A recent study by Gartner reveals more than 50% of all help desk calls are due to password issues. Additionally, Forrester estimates password resets cost organizations upward of $70 per fix. The more passwords a user has, the greater the chance of forgetting them, so SSO drives down help desk costs by minimizing password reset requests and account lockouts.
• Regulatory Compliance: Access control is central to compliance with many government/regulatory frameworks such as the Health Insurance Portability and Availability Act and the General Data Protection Regulation in the EU. SSO is one reference that can help companies satisfy these framework requirements.
• Better Security: SSO is considered one of the most secure authentication methods, helping to reduce password-related security risks, like weak or re-used credentials, and provide centralized authentication, making phishing attacks less effective. In addition, centralized control over user access and permissions makes it easier for administrators to manage identities and automates the propagation of employee account deactivation across all site and sponsor systems at exit.

SSO, a step towards system interoperability

SSO is a first step to system interoperability in that it forces companies to collaborate in a low stakes way and creates an integration even if it is only for user authentication. Nonetheless, it builds a bridge for integration between companies, both for sites logging in to sponsor’s technology as well as sponsors logging into site’s technology. This is the start of a foundational set of relationships between companies that will transform into deeper integrations and workflows. Ultimately, interoperability between source-of-truth systems across the site and sponsor technology divide is critical.

Unfortunately, less than one-third (29%) of sites say that current technology solutions deliver on their promises of interoperability and efficiency. Sites 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.

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 are disconnected from each other. SSO is one step closer, but the real solution is system interoperability.

Certainly, one way to streamline the technology burden is for sponsors, CROs, and sites to standardize on a single technology stack. However, the needs and experience of an academic medical center, hospital system, or private site are all 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 source 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, with system interoperability, 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 committee back to a sponsor’s electronic trial management file 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 and connected platform would prove valuable.

System interoperability can also minimize duplicate work and streamline document management—especially when connected to IRB review systems, which can further accelerate study startup.

“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. “Collectively, we spend an absurd amount of time manually creating pipes to connect systems. Our systems are replete with redundant manual data (re)entry. On top of that, our coordinators manage countless username/password combinations across studies and sponsors—a truly mind-numbing pain point that adds no value.”

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. Once system interoperability is delivered fully, the industry will no longer need SSO because sites will enter data once in their systems and it will flow seamlessly where it is needed in sponsors’ systems automatically (and vice versa).

Connecting the clinical trial ecosystem while simultaneously giving sites technology choice is key to reducing friction that is pervasive throughout study startup and can alleviate unnecessary burden on sites. This demands interoperability between site and sponsor systems and starts with SSO. It 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.

Stuart Cotter, vice president of technology strategy, Advarra