
Client Stories
The R&D and procurement groups undergoing transformation relied on us to streamline their sourcing strategy across clinical, safety and regulatory functions​
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The R&D group within a US pharmaceutical company was re-establishing their procurement operations post spin-off and intended to roll out multiple RFPs to CROs and Functional Service Providers (FSPs). Pharma company’s approach included not only the identification of the most optimal supplier universe for clinical operations, regulatory services, pharmacovigilance and safety services, but also had several gaps in their approach on the RFP process, pricing approach, contracts structure and SLA / KPIs.
We leveraged the best practices in strategic sourcing / outsourcing as well as our functional domain experience to provide assistance across multiple areas in the sourcing lifecycle – strategy, RFP response reviews, contract reviews and post contracting service management.
We redesigned the RFPs to be sent out to both global CRO and FSP vendors along with the MSA, pricing and other templates and identified “gaps” Vs best practices. Areas included Term of contract, creation of separate SLA and KPI sections. We also redesigned the MSAs and Exhibit sections to ensure content, terms and SLA / KPIs reflected services in scope – full service clinical trials across Phases I-IV, regulatory operations and services and pharmacovigilance / drug safety services
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Through close collaboration with leaders from clinical operations, quality, regulatory and medical writing, procurement, legal and finance, we developed SLA section that included Service Level credits to cover critical metrics such as patient recruitment, active sites, quality, cycle times, and cost.
We developed a detailed “milestone-payment” approach to align CROs payments with the promised units / deliverables / outcomes within timelines, quality, cost.
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In addition, we recommended best practice approaches for pricing negotiations to include continuous improvement, transformation and YOY pricing reductions. We also recommended best practice approaches to re-design the Service management organization (SMO)