The increased interest in process improvement that has swept across so many industries has now reached the area of clinical trials.

In a recent survey, nearly all respondents said there is an industry-wide need to unify clinical operations. This would address one of the biggest challenges facing managers of clinical trials: the disparate nature of clinical trial software systems. As many as five are used in every trial.

More than half of those surveyed said “faster study execution and improved study quality” would result from making clinical trials more efficient, according to a news release from Veeva, which conducted the study.

Unified Clinical Model

Veeva, a California-based company that provides cloud-based software for the life sciences industry, released the survey this summer.

As with most organizations and industries that adopt process improvement strategies, those who responded to the survey said streamlining the system would result in practical benefits.

Those areas of improvement and the percentage of respondents who mentioned them included:

  • Faster study execution (65%)
  • Improved study quality (63%)
  • Cost savings (59%)

That’s not a surprising list for those who work in process improvement methodologies such as Lean Six Sigma.

As things stand now in the clinical trial industry, no one unified system exists. The most popular software applications used by trial managers are called EDC, CTMS and eTMF. However, the average number of applications used on trials is four, with 36% using five.

Not surprising, 69% of those surveyed said integrating those various applications is the biggest challenge they face. Another 61% cited communicating information across multiple applications as a major problem, according to PharmPhorum.

Jennifer Goldsmith, senior vice president of the Veeva Vault CTMS system, said in the news release that the transition to a unified clinical environment is driving a streamlining of “end-to-end processes and systems within modern applications.”

Six Sigma and Software

Lean Six Sigma methodology already has had an impact on software companies across a variety of fields.

For example, the director of global learning at a California company recently told instructors at the University of California-San Diego that applying Six Sigma methods helped increase productivity, revamp qualify assurance processes and also emphasized the need for continuing statistical analysis of the company’s business model.

While process improvement has not always been as much a part of the creativity-driven software industry, it has become more valuable as software companies and processes mature.

The situation with clinical trial management is a case in point. They already have started to move away from paper records and into digital data management. They also have discovered how data analysis can help improve trial management.

However, the software issue found by Veeva is another challenge. As with many industries and organizations, managers want to eliminate the “silo” nature of clinical trials.

And just like in those other industries – from manufacturing to healthcare – the move into unifying systems and streamline processes has now taken the industry into a new level of operational efficiency.