Realize the True Benefits of Strategic Business and Digital Transformation Through a Holistic Approach with LS-SACS
STRATEGY THROUGH IMPLEMENTATION
LS-SACS is a Strategic Advisory and Consultancy Services Firm that partners with Life Sciences companies to deliver improved business outcomes across Clinical, Regulatory, Pharmacovigilance / Drug Safety and other functions.
WHAT PEOPLE SAY
Mary Lynne Bercik - Executive Director of R&D Global Procurement and Supplier Management, Organon
"I had the pleasure of working with LS-SACS and Krishnan during my tenure at Organon. Krishnan consulted and collaborated with me, our senior procurement, strategic sourcing, business and legal teams, and category leaders across multiple activities:
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Critical review of our CRO (Phase I-IV) and Functional Service Provider MSA and SOW contracts (Regulatory and pharmacovigilance functions), hands-on modifications and closure in a timely manner
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Refinement of our CRO RFP, pricing and MSA contracts to include “best in class” frameworks, service level agreements, milestone / deliverables-based payments and other strategic clauses and metrics / measures.
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Overall recommendations on improving some of our strategic sourcing and RFP process steps, commercial supplier management strategies and other areas.
Krishnan’s understanding of the clinical, regulatory, pharmacovigilance functional operating models, global sourcing and outsourcing market, various engagement and contractual models and his collaborative / flexible approach in working with procurement and business leaders was evident throughout our partnership with him. I would gladly collaborate with him and LS-SACS in any future strategy, business consulting or sourcing project" – Mary Lynne Bercik.
Services Overview
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Strategic Sourcing and outsourcing (SSO) services for Pharmaceutical, Biotechnology, Medical Devices and other clients
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Designed to deliver sustainable global and regional partnerships, improved quality and compliance, reduced cycle times and YOY cost benefits. Services cover CRO, Functional Service Providers (FSP), BPO, Technology / ITO, and Service Management Group design and implementation
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Business and Growth Strategy
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Enable start up digital SaaS 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)
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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
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Assist Private Equity and Venture Capital Firms in the identification of portfolio assets (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
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Business Operations and Performance Excellence - Clinical, PV / Safety, Regulatory and other areas
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Business and Digital Transformation - Strategy and implementation
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Digital Clinical Operating model, RACI and Governance
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Organizational Change and Communications
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IT Strategy and Technology Transformation
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Business Process Mapping / ReengineeringPM / BPR
Articles and Case Studies
Article: How to accelerate Digital Clinical Transformation through a holistic approach
Life science companies are pursuing digital initiatives across many processes, but the following seven areas are expected to deliver maximum benefits due to digital transformation initiatives:
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Efficient, real-time data access
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Sponsor systems and site selection analysis
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Technology-enabled patient systems
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Scientific analysis for program design
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Digitally-enabled patient recruitment and retention
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Risk-based and centralized monitoring
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Digital technologies to automate human processes.
While newer digital, AI, mobile, and cloud technologies are becoming available, companies are struggling to design, implement, and realize the comprehensive digital transformation benefits. Even though 90% of companies have started some type of digital transformation initiatives, only a third of the expected ROI/revenue benefits, on average, have been realized. Companies can first use a systematic digital clinical transformation maturity assessment (DCTMa)to help understand their status in the context of "best in class" methods and trends within life sciences and other industries, identify gaps, and develop a holistic digital transformation roadmap.
Article: How A Service Management Group (SMG) Can Solve Common Outsourcing Issues and deliver sponsors' clinical transformation objectives (April 2023)
A comprehensive end-to-end sourcing and outsourcing approach that is strategic in all its elements can allow life science companies to leverage best practices and realize their clinical transformation objectives. While a great deal of focus is placed on the request for proposal (RFP) process, pricing, and contract negotiations, one of the critical areas not getting enough attention is the design and development of an internal, dedicated Service Management Group (SMG) that is adequately staffed, trained, and empowered to manage the multiple suppliers and the strategic objectives of the outsourcing programs. The size and shape of the SMG depends on the size of the company or the functions that are being serviced by the group, the number of outsourced suppliers, and the strategic nature of the relationships.
Case Study: R&D Strategic sourcing and procurement advisory for a US Pharma (April 2023)
The R&D group within a US pharmaceutical company that was recently spun-off from a major Pharma, was establishing their procurement operations and rolling out multiple RFPs across 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.
LS-SACS provided assistance across multiple areas in the sourcing lifecycle – strategy, RFP response reviews, contract reviews and post contracting service management:
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Reviewed the RFPs 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,
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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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Collaborated with leaders from clinical operations, quality, regulatory and medical writing, procurement, legal and finance to develop SLA section that included Service Level credits to cover critical metrics such as patient recruitment, active sites, quality, cycle times, and cost.
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Developed a detailed “milestone-payment” approach to align CROs payments with the promised units / deliverables / outcomes within timelines, quality, cost.
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Recommended best practices approaches for pricing negotiations to include continuous improvement, transformation and YOY pricing reductions
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Provided the best practices approach to re-design supplier management to align with best practices of “Service Management Groups”
Article: Best Practices in Utilizing the FSP model: Clinical Operations, Pharmacovigilance, Regulatory and Other Areas, Applied Clinical Trials, November 16, 2021
The COVID-19 pandemic has shown that there’s a lot more flexibility in clinical trial systems than what was realized in the past. It has been a catalyst in speeding the digital process, making virtual trial conduct becoming a reality. To continue the momentum, life sciences companies need to have a dependable set of global and regional external partnerships that are flexible and scalable. These partnership models (e.g., CROs and FSPs) need to fit the diverse needs of small, medium, and large companies and a variety of “future-ready” operating models that can span clinical operations and associated functions (e.g., Clinical Data Services, PV, regulatory). 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...,
Article: Best Practices For Sourcing & Outsourcing In Clinical Operations, Clinical Leader, Guest Column, October 21, 2021
The life sciences industry is in the throes of innovation and transformation. Targeted therapeutic approaches for cancer and rare diseases and rapidly evolving genomics and molecular medicine approaches are translating into
precision medicines and individualized therapeutic protocols. Gene therapy and gene editing are beginning to transform the industry at a fundamental level. Decentralized clinical trials (DCT) are aiding the transformation, facilitating a patient-centric approach, and leveraging a variety of digital technologies. Recent application of mRNA-based platforms and expeditious trials and submissions have led to the approval of highly effective vaccines for COVID-19.....
Article: Best Practices to Ensure Sourcing and Outsourcing Are Strategic Levers for Competitive Advantage, Pharmexec.com, May 17, 2022
Companies have outsourced business process management/services and technology primarily as a cost-saving strategy over the past decade. Increasingly, organizations have been leveraging their partners for operational improvements, such as automation and migration to cloud. The trend is further shifting as they plan to accelerate transformation projects and anticipate relying on service providers more heavily in the future. This approach is complementary to their strategy of building their internal capabilities across people, process, and technology for driving strategic innovation and transformation programs. Sourcing and outsourcing can provide significant contributions to a pharmaceutical company’s competitive growth objectives, provided they are considered strategic and designed, and implemented from this perspective.
Case Study: Sourcing strategy and RFP process for selecting digital clinical systems integrators and product vendors for a major pharma
A major pharma company had developed a future clinical vision and wanted to identify the most optimal mix of systems integrators and digital clinical operations platform vendors to implement their strategy. LS-SACS worked in collaboration with the client and a leading Third Party sourcing advisory and consulting firm, in identifying the vendors that had the capabilities and vision / plan to align with the client's future clinical vision. We delivered the most optimal RFP design and structure, joint solution, contracting, negotiation and customized scoring.
CONTACT US
Life Sciences - Strategic Advisory and Consultancy Services (LS-SACS)
Edison, New New Jersey, USA