Strategic Sourcing & Outsourcing Services
"I had the pleasure of working with Krishnan, during my tenure as head of Integrated Medical Safety at Novartis. Krishnan consulted and collaborated with me and our senior pharmacovigilance leadership team in conducting an Outsourceability Portfolio Analysis (OPA) of all the safety activities. He helped us develop the business case for approval and subsequently led his Life Sciences Business Process practice team in delivering global, transformational PV ICSR and medical review services. Krishnan’s understanding of the global sourcing and outsourcing market, various engagement models, consultative and objective approach combined with his domain expertise was instrumental in the design of “Optimal Future state” PV operating model for us. I would gladly collaborate with him in any future consulting or sourcing project" - Rajesh Ghosh, Head, Digital Safety and Decision Support at Genentech
Strategic Sourcing & Outsourcing Services
Whether you need End to End Strategic global Sourcing and Outsourcing strategy and program management or need assistance with selected activities (e.g., RFP process or contracting / renegotiation or setting up Governance / Service Management Group (SMG) - LS-SACS is ready to assist.
Our services cover clinical operations (Full Service CRO), Clinical monitoring, Clinical Data Services (Clinical Data Management (CDM), Biostatistics / Statistical Programming, Data Conversions), Medical Writing, Pharmacovigilance / Drug Safety, Complaints Management and Regulatory Affairs (FSP)
We bring a unique combination of strategic sourcing & outsourcing expertise and global Life Sciences domain / functional and technology experience to ensure customized solutions that will result in the expeditious realization of your transformation objectives.
Our services secure ready access, established contracts, and agreements with global and regional CROs, FSP, Technology and other third party vendors to ensure your ability to meet the changing demand for trials, safety cases and regulatory submissions much more effectively..
Rapid Outsourceability Portfolio Analysis (OPA) as part of Sourcing Strategy Development
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
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.
Functional Service Provider (FSP) Outsourcing Advisory Services
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.
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
CRO - Full Service Advisory Services
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.
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
Design and Implementation of Service Management Group (SMG) to ensure sustainable vendor / Partner(s) relationship and steady state program management
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.
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
Transition and Transformation Management, Organizational Change and Communication (OCM) and Governance
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.
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
LS-SACS APPROACH TO STRATEGIC SOURCING AND OUTSOURCING ADVISORY SERVICES
Key activities and deliverables as part of our sourcing / outsourcing advisory projects
Development of sourcing / Outsourcing strategy that is aligned with the clinical, PV, regulatory or other functional strategies that offer flexible multi-vendor partnership models. The approach can be applied for stand-alone FSP, Full service CRO or integrated CRO, FSP and technology partnerships to align with the changing portfolio and volume of studies.
Leverage our Proprietary "Outsourcing Portfolio Analysis" (OPA) approach for evaluation of sourcing opportunities in any business function - “what, when, where and to whom”, evaluate risks and mitigations, and formalize business case and roadmap
Ensure rapid collection of baseline metrics with potential to leverage AI / ML technologies, templatized RFP creation and distribution to reduce sourcing start-up timelines by at least 25-30% "("Digital Sourcing")
Identification of most optimal vendor partners list for receiving the RFI / RFP, that meets comprehensive needs of the client from a future portfolio, geo, type of trials, TA, submission needs etc., perspective
Ability and expertise to customize the RFI / RFP in close collaboration with client business, technology and procurement organizations
Leverage “Best in class” vendor scoring templates that can be easily customized to meet the client specific requirements and objective evaluation
Evaluation of optimal pricing / commercial models - FTE, Fixed bid, deliverables (per study, per visit, CRF, SAP, TLF, CSR etc.,), risk-reward and outcomes-based and qualitative aspects (e.g., culture, vision, commitment to partnership outcomes) that fits the client needs.
Coaching of the cross functional client team on scoring, negotiations, contracting, and post contract transition, transformation, and steady-state vendor(s) management
Design and implement “Best in Class” governance structure, forums, escalation and communications that ensure participation from appropriate client and vendor leadership teams and dashboard to track and monitor progress of the partnership objectives in real time
Develop and assist in the implementation of a practical innovation and transformation roadmap that includes gated milestones, deliverables and metrics-tracking, with shared and specific accountabilities borne by the vendor partner(s)
Proven expertise in multiple FSP models and service areas – Clinical Monitoring, Clinical Data Management, Biostatistics and programming, Medical Writing, Regulatory Affairs, Pharmacovigilance / Drug safety and Complaints management
Life Sciences - Sourcing Advisory and Consultancy Services (LS-SACS)
Edison, New New Jersey, USA