Strategic Advisory Services: Sourcing / Outsourcing Advisory AND Business Strategy and Growth Advisory 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
I. Sourcing and Outsourcing Strategy and Implementation for reduced time to market and cost, improved quality, compliance and customer satisfaction
Rigorous 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 effective Supplier Relationship Management (SRM) 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
II. Business Strategy and Growth Advisory Services
Enable start up digital SaaS (Small businesses / Start Ups) companies with business and Go To Market strategic planning, organization structure and operating model, product strategy, partnership approach, and funding plans (e.g., Pitch decks, financial planning)
Assist global CRO, BPO and ITO services companies in refining their Go To Market solutions, account growth and expansion plans, coaching account teams and other areas
Assist Private Equity and Venture Capital Firms in the identification of portfolio assets across Healthcare / Life Science tech companies, business consulting firms and CRO, BPO and IT services companies, evaluation and due diligence, investment recommendation, and advisory board level participation
Life Sciences - Strategic Advisory and Consultancy Services (LS-SACS)
Edison, New New Jersey, USA