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Client Stories 

Pharmacovigilance Transformation and  Strategic Sourcing for a mid-tier Biotechnology Company

Client Stories

By leveraging best practices in PV Operations & Sourcing, we managed the end to end sourcing & outsourcing  program for an Oncology focused biotechnology company. 

 

The pharmacovigilance, quality and regulatory function of a mid-tier biotech company was planning to transform their PV / patient safety function and was facing challenges with the quality and deliverables of their existing PV provider.  They needed to identify a strategic PV partner in an accelerated timeframe that can become part of their extended team and also be an active participant in the transformation.

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We conducted scenario analysis with the PV team and the C-level leadership of the company and led the end-to-end sourcing program through a customized and accelerated process.  We customized the sourcing program to fit the needs of the mid-tier biotech company and their strategic needs and developed the sourcing strategy in close collaboration with the PV, quality, procurement and legal teams and received approval from the CEO. 

 

Our approach included a rapid “as-is” situation analysis covering the key challenges across the partnership, day to day services and the client’s transformational needs, internal PV operating model / gaps and the SOW / MSA contracts with the supplier(s). 

 

Using our customized SnB for SMB (Sourcing in a Box for Small and Medium Sized Business), we developed and completed customized RFI and RFP in a rapid timeframe - with a set of suppliers that fit the company’s TA and geography focus, transformation needs across process and technology platforms and the need for a partner with proven track record in PV services.  We led the development of a detailed SOW that included content, unit / deliverables-based pricing terms and SLA / KPIs (penalties and rewards) that reflected future operating model in close collaboration with the legal and procurement teams.  We also recommended refinements to the MSA to ensure alignment with the industry trends.

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We trained the core as well as the extended client teams, conducted negotiations with the supplier and delivered an outcomes based contract and a joint operating model that allowed for transactional services at a lower cost and higher services delivery as well as transformational objectives.   

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Our collaborative approach and expertise resulted in a multi-year contract for the client with guaranteed Year Over Year savings, unit-pricing for >90% activities, SLA and reduced cost of operations by more than 55%

Interested in discussing your pharmacovigilance, regulatory, clinical operations,  data sciences transformation or other functional strategy   external partnership needs? Our experts can help...

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