A clinical development team in a large pharmaceutical company required a different approach to drug development for its new therapy product.

The organization was experiencing several human factor impediments in meeting this challenge; there was finger-pointing, a lack of collaboration, lack of work structures and processes, lack of communication, lack of inspirational leadership, dysfunctional and fragmented teams, as well as inappropriate team behaviors.

Insigniam’s pharmaceutical consulting expertise was utilized to work on three consecutive projects over a period of 18 months. Over the 18 months, the organization produced many outcomes. They completed a RACI chart (Responsible, Accountable, Consult, Inform) for each study in the new therapy development program, including clarifying functional roles and responsibilities. They identified processes that needed to be retired, improved, or started. They conducted a full process redesign complete with data review, protocol review, patient profiling, and an on-boarding process. They reviewed and enhanced team-operating structures, including the structure for meetings. They also established a clinical submission team playbook.

This new level of team coordination, collaboration, and structure facilitated their ability to reach the organization’s business imperatives.

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