Clinical Development – Examples

Clinical development is constantly evolving. Realizing strategic goals in clinical development requires deep knowledge of GCP, operational excellence in clinical operations, outsourcing best practices and the challenges of global trials.

 

Pharma Initiatives has decades of experience creating the strategic direction and operational infrastructure needed to consistently achieve goals in clinical development. Examples of our work in clinical development include:

  • Defined the strategic use of in-house resources to complement a “virtual pharma” outsourced model of a midsized, growing pharmaceutical company to drive better project control, deeper stats knowledge and greater ownership over site relationships, leading to a 31% reduction in CRO change orders.

 

  • Redesigned the clinical operations function and core processes for a global top-20 pharmaceutical company, with an emphasis on harmonization globally, the tactical use of outsourcing and the use of new approaches like adaptive trial designs and risk-based monitoring. Improved trial performance on average by 22% across all trials in the two years following implementation.

 

  • Defined the organization scaling strategy for the clinical development function of a high-growth biologics company, including in-house vs. outsource skills, the required clinical development SOPs and which IT systems were needed, and then implemented the changes to support 300% growth each year for three years.

     

  • Defined the requirements for a replacement clinical trial management system for a top-five clinical research organization, advocating that the company use commercially available software with no modifications by modifying their internal procedures. Gained multi-level agreement on this approach that led to record setting implementation timelines of less than nine months.

     

  • Designed quality and speed into the baseline of a new protocol development process for a midsized pharmaceutical company leading to a 50% reduction in the timeline, and then at a later date used that same model as the basis for the North American standard protocol development process when the company was acquired by a larger, global pharmaceutical company

     

  • Developed new processes and redefined roles to support increased speed and quality in clinical data management and statistical analysis plan development processes for a large pharmaceutical company, leveraging software-as-a-service statistical software and on-demand, pre-negotiated functional outsourcing relationships to support peak times.