Pharma Expansions, Mergers and Acquisitions - Clinical Operations - De-centralization vs. Centralization

Recently and due to expansions, mergers and acquisitions, I was approached by pharma to assess and develop and implement a more centralized clinical operations function. With a pipeline of promising new products and rapid growth, the pharma's clinical operations organization expanded considerably and rapidly, becoming fragmented. This fragmentation generated operational inefficiencies and lethargic performance due to several business models existing under the same roof, serious communication issues, a loss of focused leadership, a de-centralized team, duplication of resources, capacity, responsibilities and accountabilities. Certainly, in addition, lost timelines, target dates and quality were sacrificed in the expansion.

This is now a common issue throughout the pharma industry with current expansions, mergers and acquisitions. The assessment required the development and implementation of a new internal and external re-structure, plan and operational process moving forward. The new structure included a good deal of re-work pertaining to, but not limited to, internal and external functions, outsourced resources, leadership, management and strategic planning.

As the pharma company prepared for its first clinical and regulatory submission to FDA, EMEA, and product launch, there was a great need to identify, process and communication bottlenecks and determine which of its functions required the most improvement in a limited time. Short term, long term objectives. Gaps and stumbling blocks in the pharma company's processes were identified and worked through to improve the pharma company's clinical trials operations, performance and quality, good clinical practice. In-depth assessments, process and quality forensics, data and documentation audits focused on short and long term objectives, outlining the best practices. Opportunities for improvement were assessed and implemented. The implementation plan was agreed upon by all functions, all teams, all CROs, inhouse and outsourced, external. An implementation guide was developed for the pharma and was critical to the execution of the prioritized recommendations. Bridging the gap between corporate leaders and operational staff, team and functions was the main key to improvement. Re-build and revise, budgets, processes, standards of operations, plans, optimize alliances, internal and outsources and maximize efficiency and leadership. Key short term objectives.

• Optimize focus groups of operational staff, CRAs, CTMs to solve operational problems as they arise.
• Provide a no consequences feedback mechanism from operational staff to corporate leadership thereby opening communication.
• Perform a where, when, who and why responsibility trail and train to clarify roles and decision makers.