Veeva Systems recently released a report examining the industry’s progress as it pertains to unifying clinical systems and streamlining trial processes. According to the report, contract research organizations (CROs) lead sponsors in adopting purpose-built clinical applications.
View: Infographic: Unifying clinical operations
Compared to last year, Jim Reilly, VP of clinical strategy, Veeva Systems, said the main change in survey results is the progress and level of investment in modern eClinical solutions – a market which is expected to grow at a compound annual growth rate of around 12% to potentially reach beyond $13bn by 2024.
As Reilly explained, Veeva is seeing companies adopt new applications that are more advanced, in addition to platforms in other areas of clinical operations, such as trial master file (TMF) management.
According to the report, the number of CROs now using purpose-built electronic TMF (eTMF) applications has more than doubled since 2014. Today, more than half (54%) of CROs use a purpose-built application versus 21% in 2014 and 42% in 2017.
Reilly added, “In particular, 80% are taking steps to improve study start-up, which supports the finding that CROs are making investments in technology to improve trial efficiency and simplify collaboration with study partners.”
What’s driving change
Per the report, collaboration continues to be a challenge, one cited by one-third (33%) of CRO respondents. “This explains why all CRO respondents report the need to unify their clinical applications, and 91% say their organizations have, or plan to have, an initiative in place to do so,” Reilly told us.
Additionally, he noted that as the industry becomes more competitive, technology can provide differentiation, allowing CROs to deliver more tailored offerings. “It’s why CROs have are making significant progress in modernizing trial processes with purpose-built applications,” said Reilly.
Operational efficiency also remains a major focus and driver of progress.
“CRO’s operate as margin-based businesses, where containing costs is crucial to driving the bottom line. In addition, because of the nature of their business, they manage clinical operations on a large scale with vast amounts of data throughput,” explained Reilly, adding that purpose-built platforms enable further efficiency and support this needed scale.
The challenges
According to the survey, integrating multiple application is the biggest challenge organizations face with clinical applications (74%), followed by reporting across applications (62%), and managing content and data across applications (62%).
“Many of the challenges CROs and sponsors face today in managing clinical trials stem from the disparate nature of their processes and systems, and the significant cost and complexity of integrating these clinical applications,” said Reilly.
However, he noted the opportunity to transform clinical operations by unifying clinical environments. “A unified model brings together best-in-class applications on a single cloud platform,” he added. “CROs now, for the first time, can manage the entire clinical trial process and gain a global view into trial status, improving efficiencies and streamlining operations.”
Making progress
Despite the challenges, Reilly said the industry is “absolutely” making real progress toward unifying clinical operations.
“The shift to a unified clinical landscape presents exciting opportunities for the industry to rethink how clinical trials are executed and managed. It’s why we’re seeing the significant shift toward modernizing clinical trial processes,” he explained.
Unified clinical trial operations provide transparency into trial activities, from study start-up to completion, which he said makes it easier for CROs to work with sponsor and sites.
Reilly added, “The change underway will enable the industry to better manage the growing complexity of trials, and ultimately, accelerate time to market.”
