Rapid Outsourceability Portfolio Analysis (OPA) as part of Sourcing Strategy Development

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To ensure that sponsor’s FSP plans are strategic and deliver both near- and long-term objectives, sponsors are best served by conducting a detailed OPA that provides a comprehensive mapping of processes, sub-processes and activities that are core (retained) and non-core to them (that can be outsourced to external vendor(s)). This will answer “What, When, How, Where and To Whom” along with the risks and mitigations. 

 

Typically, the OPA analyses takes ~6-18 weeks, depending on the function(s) to be analyzed, global Vs regional nature of the function, maturity of the sourcing experience of the client etc.,  Activities for analysis are drawn from sponsors’ SOPs to ensure accuracy and "buy-in" from operational teams and key OPA deliverables include detailed “Outsourceability Matrix”, business case, cost and risk-benefit analysis, and roadmap for implementation

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LS-SACS has conducted numerous OPA analyses that were customized to fit several functions including CDM, Biostatistics & programming, Pharmacovigilance, Medical Writing, Medical Affairs, and Regulatory Affairs.  

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Functional Service Provider (FSP) Outsourcing Advisory Services 

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As the name indicates, the FSP model describes the engagement model utilized by sponsors with partner(s) to outsource either most of a function’s activities or a limited set of activities. The engagement model can be either FTE (cost of resource/hour) or unit/deliverables based (e.g., number of Case Report Forms (CRF), Tables, Listings, Figures (TLF), PV cases, and number of visits). In an environment where sponsors are challenged to manage their staffing capacity, with a broad set of skills needed in the face of dynamically changing clinical study or PV case volumes, the flexibility and scalability of the FSP model allows sponsors to manage the demand more effectively.

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LS-SACS expertise and approach can guide clients from the optimal design to the successful implementation of the FSP partnership and/or in a hybrid model with other CRO and / or technology partners

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CRO - Full Service Advisory Services 

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Transformation of clinical operations across processes, people, and technology has become a strategic priority, as nearly 70% of R&D spend is on clinical trials. Since a significant portion of clinical trials are outsourced to external partners (e.g., CRO, FSP), it is imperative that life sciences companies have a dependable set of global and regional external partnerships that are flexible and scalable. These partnerships need to fit the diverse needs of small, medium, and large companies and a variety of “future-ready” operating models.

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A comprehensive and collaborative outsourcing approach that is strategic in all its elements from LS-SACS can allow life sciences companies to leverage best practices and realize their clinical transformation objectives

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Design and Implementation of Service Management Group (SMG) to ensure sustainable vendor / Partner(s) relationship and steady state program management 

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Major drivers of client's outsourcing initiative are the basis for a well rounded Service Management Group (SMG) with clearly defined goals, roles,  responsibilities and continuous improvement / transformation outcomes.   The SMG will play a more significant and critical role as the number and complexity of global and regional vendor(s) and partner(s) increases across the various functional areas, including technology.   

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LS-SACS has designed and implemented SMGs for clients of various sizes and needs and can ensure the optimal design to assist in your own needs and expected outcomes

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Transition and Transformation Management, Organizational Change and Communication (OCM) and Governance

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Whether you are implementing a FSP or CRO or blended model with or without technology providers, LS-CSA can assist in the planning and implementation of the program incorporating the best practices of OCM into the plan seamlessly.  This would include milestones and their commercial and business impact and "go-no go" decision criteria for next steps.  We will also leverage and customize the best practices in governance structure, forums, participation and  inputs / outputs based on implementations at more than 100 small, medium and large clients.  

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LS-SACS has designed, implemented complex transition and transformation management plans across various engagement models that included multiple vendors / partners and can ensure the optimal design to assist in your own needs and expected outcomes