This blog is the second part of a two part series. You can read Part 1 here.

Crossing the finishing line

Streamlining SSU

The clinical trial landscape is ripe for bringing substantial improvements to the SSU process. As discussed, there are challenges posed by the many steps involved in SSU coupled with the industry’s overall lack of rigorous data collection needed to calculate performance metrics. Much of the information used to launch clinical trials often resides in multiple databases, and SSU tends to be conducted using Excel spreadsheets, e-mail, e-rooms and shared file drives. As a result, much time is wasted in status meetings as the desired information is not readily available. Fortunately, these meetings can be eliminated or reduced as current technology allows for efficiencies using cloud-based systems that automate processes, increase visibility and improve collaboration with sponsors, CROs, sites, regulators, and review boards.

A purpose-built SSU solution is the missing piece in a world of electronic tools that are widely adopted for more efficient study conduct, such as CTMS, eTMF, EDC, and more recently, eSource. For example, according to the 2013 Clinical Trial Management Survey by eCliniqua and BioClinica, approximately 60% of respondents use digital software, such as CTMS, to manage clinical trials. A 2014 survey conducted by Veeva Systems found that 21% of CROs and 15% of sponsors use an eTMF application, and a content management system is used by roughly one-third of sponsors and CROs.

SSU solution
Figure 1

Speeding SSU sets the stage for bringing much needed process efficiencies across the entire lifecycle, starting with allowing users to be proactive by viewing information in real-time. Activate, for example, is a purpose-built SSU solution by goBalto, which enables real-time viewing through smart workflows that standardize processes. This solution also guides study teams to complete and track study-related documents and tasks required for any site, country, or study based on company-specific standard operating procedures or internal processes. If study requirements change, Activate’s workflows can be updated accordingly. Also, this application functions as a single repository for in-progress documents, and information only needs to be entered once.

Activate uses an application program interface (API) to integrate with the other eClinical operations—the “clinical stack”—to optimize the clinical trial continuum by allowing information to flow among the various integrated components (Figure 1). It is also designed to provide better collaboration with sites and improve business processes (Chart 1). Moreover, documents from the principal investigator’s (PI) database and the investigator portal can be accessed via a single logon. Together, all of these benefits function as major timesavers in site activation.

goBalto cites a case study of a major pharmaceutical company using Activate in all of its US sites that conduct oncology trials. Prior to the implementation, the company reported having no automated task assignment, had heavy reliance on manual spreadsheets for progress reports, no view of work in progress or real-time study startup status, and no mechanism for identifying bottlenecks. After an eight-month implementation, the company experienced a 32% reduction (in weeks) in SSU. This included receiving essential documents from sites in 17 weeks instead of 30, and completing contracts and budgets in 3.5 weeks instead of 4.2 weeks.

A Better Process

Many of the steps involved in SSU create delays, but with the advent of purpose-built cloud-based technology, electronic solutions can make a disruptive impact by shortening clinical trial cycle time. Research from the Tufts CSDD indicates that a 10% improvement in the clinical trials process may be tied to a $250 million savings from reduced cycle time. Even a more modest 5% improvement may be associated with $102 million in savings tied to shorter cycle time.

Benefits if a Cloud-Based Solution that speed SSU
  • Regularly collaborate with sites
  • Improve business processes
  • Exchange documents
  • Identify bottlenecks
  • Avoid redundant processes
  • Review and normalize processes (to enable global metrics)
  • Consolidate information in one place
  • Predict progress more accurately
  • Drive data-based business decisions
  • Set global milestones
  • Access study data anytime, anywhere
  • View global study status

Chart 1

With better SSU processes, the focus can shift from monitoring to better collaboration with sites. Through automation, all of the documents reside in a central location, allowing sites to be easily and gently reminded of outstanding tasks that need to be fulfilled. This approach helps to improve the relationship between sites and CROs as sites are not constantly being called or e-mailed in pursuit of specific documents. As for sponsors, an electronic SSU solution allows them to focus on true market differentiation as they have real-time access to status updates, enabling faster action, instead of waiting to hear from the CRO for this information.

Importantly, the data contained in a robust SSU application addresses the industry’s longstanding problem of not collecting sufficient metrics to document the status of how a study is starting to unfold. It is also a critical addition to the ongoing clinical trial automation through integration with eTMF and CTMS systems. It is the last piece of the clinical trial continuum to be automated, and the one with a promising ability to cut costs by shortening timeframes to development of therapies needed by patients worldwide.