Governance, Issue Management & Oversight
Guiding the process for managing and resolving a performance issue at a preferred provider of CMC and analytical chemistry services for a global pharma company.
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- The company had a small selection of preferred providers for analytical chemistry services, supporting the CMC development of new products.
- The performance level of one supplier started showing a marked downturn, resulting in a shift in attitudes within the business and operational teams, which made working with them considerably more difficult.
- Additionally, the base rates and overall costs for the supplier were 10% more than the other suppliers in the pool.
- Several incidents brought the situation to a head to such an extent that, whilst ongoing studies were maintained, the supplier was put on hold for any new work.
- The initial step was to understand the nature of the problem and the desired outcome for the sponsor, who invested time with the supplier and did not want to walk away from the relationship immediately.
- The 4C team facilitated and moderated discussions between operational and business focused groups at the Sponsor and CDMO level, which required careful management to ensure open and constructive dialogue.
- Over several meetings, the sponsor was able to clearly articulate their needs and concerns over performance. Through a root cause analysis, the service provider received process improvement guidance on where there were inefficiencies and issues within their processes.
- We agreed with the parties on a deadline for reporting back on new processes and improvement initiatives and reviewed plans with the sponsor, prior to deciding whether to reinstate the supplier.
- Significant improvement from the lowest level to out-performing all KPIs when measured against the other preferred providers was achieved.
- Process improvements and efficiencies resulted in a 20% reduction in proposed costs without impacting the profitability of the service provider.
- Improved company to company relationships led to easier, more effective working relationships at all levels and maximum value delivered to the patients.
- The application of these processes drove improvement activities and benefits across all clients and increased their competitiveness.