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Accelerating Large, Complex Clinical Submission on Blockbuster Drug

A pharmaceutical company was working on a large and complex clinical program, targeted to be a blockbuster drug. The clinical submission involved 20,000 patients and was one of the largest trials in the world to date. To add more complication to coordinating the project, there were 36 work streams with 12 additional clinical studies. This project was cross-cultural with people in the UK, Sweden, and the USA.

The CEO had promised a 4th quarter submission, which seemed utterly impossible to the team.

The Director of the clinical trial hired Insigniam to work with this global clinical team on Breakthrough Project management. During the Breakthrough Project two-day kickoff meeting, the team aligned upon and committed to an 85-day submission deadline, instead of the unrealistic 60-day submission that they originally had. This goal would still enable them to submit in the 4th quarter.

Insigniam’s pharma-consultants met with the team every week to ensure the project was on track and facilitated the resolution of any breakdowns. They coached the core-team, seven project managers, the lead medical writers, the lead bio-statistician, the lead programmer, the lead of Regulatory Affairs, and the lead project manager to support their success.

With focus and determination, this committed team met the deadline for their submission, a breakthrough result that was once seen as utterly impossible to achieve.  They met the CEO’s promised 4th quarter submission and enabled the company to achieve speed to market with this potential blockbuster drug.