Services

E2E Development Acceleration

Our proven approach centers on four pillars: Strategy, Innovation, Process Optimization, and Human Capital Empowerment. We drive leadership alignment, define clear intent, and identify initiatives that streamline development using Lean/Six Sigma, automation, and AI. Through strong change management, we deliver measurable transformation that generates millions in revenue value for biopharma organizations.

Case Studies

50% Filing Time Acceleration

 

Halving the market approval filing timeline for a late-stage development organization.

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Insights

Challenge: A Top 5 biopharma sought to shorten its market approval filing timeline by half. This goal required a complex, multi-year, cross-functional transformation across Clinical, CMC, Clinical, Safety, Data Science and Regulatory. The client needed a central PMO office to provide strategic leadership and coordinate this large-scale transformation program.

Approach: We analyzed the Critical Path from Database Lock to submission, identifying processes that introduced variability, risk, or timeline delays. We led cross-functional teams to develop streamlined processes and rolled them out across filing teams. This iterative work—supported by a central “program control center”—focused on accelerating key bottlenecks and instilling a mindset for sustainable change.

Impact: We successfully accelerated the filing timeline by 14 weeks and reduced filing performance variability by 50%. The transformation delivered $49M in revenue value per submission. We installed a centralized performance tracking and process network team for continuous improvement.

Reducing Trial Cycle Time by 6+ Months

 

Successful acceleration of development, reducing trial cycle times by over six months.

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Insights

Challenge: A mid-sized pharma company sought to accelerate its development programs in a high-quality and efficient manner. The client aimed to optimize the entire clinical ecosystem—including company practices, CROs, vendors, sites, and patients. A comprehensive transformation was needed to achieve radical efficiency across all clinical trial stakeholders.

Approach: We established a transformation program with seven distinct tracks focused on achieving the goals. These tracks included introducing new technologies, standardizing templates, mapping end-to-end processes, and ensuring quality throughout the study. We followed detailed implementation plans to address the entire clinical ecosystem.

Impact: The project accomplished all identified goals reducing trial cycle times by >6 months and increasing resource utilization by >33%. We delivered >50 separate solutions, including a new data warehouse and risk-based quality management. Sustainment plans were established to embed the transformation permanently.

CMC Module 3 Acceleration

 

Redesign of the E2E Module 3 submission process, achieving a 50-day cycle time reduction.

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Insights

Challenge: A rapidly growing mid-size biopharma company anticipated an increase in submissions, necessitating an end-to-end Module 3 Process Redesign. The goal was to remove Module 3 from the critical path of regulatory submissions and increase quality to reduce re-work and Request to Questions, thereby improving scalability and sustainability.

Approach: We facilitated workshops to map the current and desired future state process flow for Module 3. After conducting a gap analysis, solutions were created by partnering with key client SMEs and implemented as pilots across upcoming major submissions. The approach focused on driving upfront strategy and clarifying roles and responsibilities.

Impact: The project delivered a 50-day cycle time reduction and yielded 2,600 FTE Hours in productivity gains. The process harmonization and automation improved quality, increased employee satisfaction, and drove increased alignment and trust.