Fortune 100 pharmaceutical company: reducing clinical trial cycle

The Challenge

A leading pharmaceutical company’s product development division was amidst the clinical trials phase for a new drug, facing intense competition. The vice president sought to expedite the trial process to secure FDA approval ahead of competitors. Each day saved was valued at over a million dollars. The Product Development Team, having worked for a year on a two-year study, faced numerous unresolved issues, including documentation errors and vendor performance problems, hindering their ability to meet deadlines.

The team was pessimistic about meeting the six-to nine-month timeline for completing the data retrieval and reporting phase, let alone reducing it. They were bogged down by errors, vendor issues and a negative mindset, believing they couldn’t affect the timeline. The critical challenge was to overcome these obstacles, streamline processes and significantly cut down the cycle time from the last patient visit to the final report.

The Approach

Our experts engaged a multi-functional sub-team to challenge the existing assumptions and processes. The team committed to a radical goal of a ten-week cycle time. They reinvented data collection, cleaning and reporting processes, and redefined relationships with vendors, fostering a virtual partnership that enhanced efficiency and accuracy. The team also collaborated closely with clinical sites to improve documentation accuracy. We provided continuous coaching to maintain the team’s commitment and tackle day-to-day challenges.

The Impact

The team successfully demonstrated the ability to complete the cycle in ten weeks during trial runs. This achievement led to further efforts to shorten the timeframe and improve other phases of the development process. Although an ancillary study paused the drug’s market release, the team’s innovative processes and partnership models gained widespread recognition within the company. The leaders received promotions and the breakthrough methods were integrated into other projects, setting a new standard for the company’s drug development processes.