Oversaw a rapid, 8-week integration of new CRO acquisition
Built the integration plan for a new, overseas CRO acquisition prior to deal close, then rapidly deploy the integration plan to drive alignment of organization, process and business development. Developed a longer-term systems alignment process and continuous improvement process.
Clinical Research Organizations
Successfully selected and implemented a CTMS system after client failed in initial effort
After a failed attempt by the client to implement a CTMS System, developed improved requirements for the client’s CTMS, used those requirements to rapidly select the best-fit system, and drove fast configuration to implement the system only marginally behind the original schedule.
Developed enhanced start up process – improving efficiency by 25%
Designed a metrics-driven specialized Start-Up Function, gained senior leadership alignment and then rapidly deployed new processes and tools to launch the function ahead of schedule.
Improved trial performance by 22% across all trials
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.
Clinical Operations
Pharma Initiatives 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.
Created a 31% reduction in CRO change orders
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.
Implemented changes to support 300% growth each year for three years.
Increased medical affairs involvement in formulary committee presentations by 75%
Created new processes for field medical personnel to assist in their effective interactions with their access and reimbursement peers for a top-20 pharmaceutical company, leading to a 75% increase in medical affairs involvement in formulary committee presentations.
Medical Affairs
Developed a medical information function leading to a 50% savings in treatment launch
Developed medical information function to support the launch of a treatment in a new therapeutic area for a midsized biotechnology company, saving 50% of the costs of outsourcing the function as originally planned.
Created a medical affairs functional development plan to support leadership in less than 12 weeks
Created the medical affairs functional development plan for a small biotech, seamlessly transitioning from external consultant support to internal, Medical Director-driven, medical affairs leadership in less than 12 weeks.