Whether your transformation focus is across the company or within selected functions / business units - R&D, clinical operations, pharmavogilance & patient safety, regulatory affairs, medical affairs and commercial, procurement & supply chain or other areas - LS-SACS has the consulting and technology experience and life sciences domain expertise to deliver your desired outcomes.
Let us partner with you in your transformation journey - from strategy to target business and AI digital operating models / processes (TOM / TOP) to phased implementations - together we can unlock enterprise resilience, cut time-to-market, improve quality and compliance, and ensure regulatory certainty
AI-led digital and business transformation
Industry Context and Opportunities
Holistic Ai-led Digital Transformation Framework (HAiDMA)
Balanced Score Card for Ai-led Digital Transformation
Digital Clinical Maturity Assessment (DCMA)
Life sciences industry is leveraging AI-driven digital technologies to drive innovation in many areas, including patient recruitment, trial design and optimization and regulatory compliance and automation.
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​Newer digital, AI, mobile, and cloud technologies are becoming available along with the unprecedented collaboration between life sciences companies, governments, and regulators. 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.
To be successful in their efforts and create transformational value, organizations and individual functions need a holistic "Enterprise Digital with AI" approach across strategy, process, technology, data, and people
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LS-SACS' has developed a customized and holistic approach for the design and implementation of successful digital and business transformation strategies. Key components include: ​
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Holistic Ai-led digital transformation framework (HAiDT) that starts with an agile digital transformation strategy
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A 10-parameter Ai-led Digital Maturity Assessment (DCMA) is developed based on cross-industry best practices and our own experiences with life sciences leaders.
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Develop a phased implementation roadmap with targeted initiatives and tangible outcomes.
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DCMA is customizable to any of the functional needs (e.g., clinical, PV, regulatory, medical affairs).
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DCMA also covers critical aspects such as digital strategy, risk and compliance, data / AI tools and technologies, AI governance and KPIs
Key Benefits:
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"Best-in-class" holistic digital transformation strategy
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Balanced Score Card (BSC) that seamlessly links strategic outcome metrics with financial, operational, and staff capabilities
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Ai-led digital maturity assessment, gaps Vs benchmarks and 'future state" processes, technology and skills needs (as part or strategic workforce planning - SWP) across the company
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Ai Vs human tasks by the selected function / business unit
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Phased roadmap for implementation
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Organizational change and communications to enable digital operating model
Digital Clinical Operations (DCO)
Industry Context and Opportunities
Clinical Trial Failure & Delays: ~85% of clinical trials face delays, primarily due to slow patient recruitment, which massively inflates costs and delays revenue generation.
Data Fragmentation & Quality: Scientific, clinical, and commercial data are locked in siloes across legacy systems, preventing the holistic, real-time insights required for AI model training.
AI Led Digital Transformation Challenges: Numerous pilots, lack of overarching digital strategy and implementations, lack of an aligned Strategic Workforce Planning (SWP) and change management / governance lead to only partial realization of benefits
AI and Digital Interventions across clinical Operations
Services
Our approach is to assist life sciences companies in driving the strategic transformation of clinical trial execution (planning, conduct, monitoring, analysis) by leveraging digital technologies (e.g., cloud platforms, wearables, remote patient monitoring) and advanced data analytics (AI/ML/NLP).
We collaborate in the development of the optimal "To-be" digital operating model (TOM) across process, people and technology in tune with best practices and that fits the client's strategy and vision. ​
We believe that the following seven areas will have a major impact on the success of digital clinical trials
Our DCO services include the review and refine the roles and responsibilities of the staff to fit the future DCO operating model
Clinical Data Sciences (CDS)
Clinical Data Sciences (CDS) is evolving into an advanced, interdisciplinary field that builds upon traditional Clinical Data Management (CDM) by integrating data science, machine learning (ML), and Real-World Evidence (RWE) to drive strategic decision-making in clinical trials and research.​
Services
​LS-SACS assists clients in their efforts to transition from data integrity and analytics to "data intelligence". We leverage domain experts and our technology partners to redesign the internal processes and workflows using advanced analytics (Machine Language (ML) and Natural Language Processing (NLP) to accelerate real-time decision-making. We anticipate a 30-60% efficiency gain, depending on the client context and the extent of technology leverage​
Medical Affairs
Context and Opportunities
Data Overload & Scientific Literature Volume: The explosion of new research (genomic data, RWE, publications) makes it impossible for MSLs (Medical Science Liaisons) to keep pace manually.
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Operational Inefficiency & MLR Bottlenecks: The Medical/Legal/Regulatory (MLR) review cycle for scientific content is slow and manual, delaying time-to-market for educational materials.
​Stakeholder Engagement & Reactive Model: MSLs spend too much time handling basic inquiries and insufficient time building deep, strategic relationships with Key Opinion Leaders (KOLs).
​Compliance & Risk & Off-Label Inquiries: Handling unsolicited requests for off-label information requires meticulous, compliant documentation and response, which is time-consuming and high-risk.
Services
Target Operating Model Redesign: End-to-end submissions process redesign - Redesigning the entire MA workflow to embed AI/digital tools, shifting personnel from manual data work to scientific strategy and insights analysis
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Strategic Workforce Planning and Redesign: As MA moves from basic automation to agentic AI implementations, SWP needs to align to ensure roles and responsibilities are redesigned to distribute tasks between humans and agentic AI.
Pharmacovigilance (PV) and Regulatory Affairs
Pharmacovigilance / Patient Safety
"Proactive" Patient Safety
​As the pharmaceutical industry expands its portfolio of products (e.g., Cell Therapy, Gene Therapy) and global reach, they are also shifting their focus from being “reactive” and push towards a “proactive patient safety” culture, processes, and technologies.
Services
LS-SACS assists clients in the development of a global 24x7 "proactive safety" operating model, process redesign and redesigned staffing / roles and responsibilities along with the training needs to fit the new models. The approach will allow clients to become nimble and improve their ability to manage varying global case volumes effectively and be able to reduce the submission timelines for the various safety reports ​
Regulatory Affairs
Regulatory Affairs
LS-SACS assists clients in the development of a global 24x7 regulatory operations operating model, process redesign and redesigned staffing / roles and responsibilities. Our focus is to assist in our client's efforts to deliver "first time right" quality and "zero compliance errors.
We leverage our network of regulatory experts and AI / digital technology providers to improve the efficiency of the most manual efforts in the regulatory process.
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End-to-end submissions process redesign - Optimize the entire workflow from technical writing to final publishing
​GenAI Drafting Copilots: Building and validating GenAI assistants that draft routine sections of a CSR, safety summaries, or Medical Information responses, cutting writing time by 30-50%.
Strategic Sourcing and Outsourcing
Transformation of R & D / clinical, pharmacovigilance / safety, regulatory, commercial and other functional areas has become a strategic imperative, 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 end-to-end sourcing and outsourcing approach that is strategic in all its elements can allow life sciences companies to leverage best practices and realize their clinical transformation objectives.
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Services
LS-SACS has developed a series of customized and targeted services across the sourcing and outsourcing lifecycle: ​
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Sourcing / Outsourceability Portfolio Analysis (OPA) to ensure sourcing strategy is aligned with the corporate and functional strategies of the company and provides a plan that is risk-mitigated.
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"SnB for SMB" - Sourcing in a Box for Small and Medium pharmaceutical, biotechnology, and medical Devices Businesses - The approach can reduce the overall timeline and cost of outsourcing process by 20-50%, in addition to reducing the cost of operations by 30-50% for Emerging biotech companies.
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Functional Service Provider (FSP) Outsourcing Advisory Services
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CRO - Full Service Advisory Services
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Design and implementation of a Service Management Group (SMG) that allows for rigorous management of the sourcing programs and KPIs / outcomes.
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Transition and transformation management, organizational change management (OCM) and governance.
Outsourcing Portfolio Analysis (OPA)
Rapid "SnB for SMB" Process
Service Management Group (SMG)
Structured Governance
Organizational Change and Communications
Transformation of R & D / clinical, pharmacovigilance / safety, regulatory, commercial and other functional areas has become a strategic imperative for the life sciences industry. There are numerous internal and external drivers of change and the nature and scale of change is becoming increasingly significant.
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LS-SACS has customized best practice organizational change and communications (OCM) approaches and methodologies to meet the changing needs of our life sciences clients: ​
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An OCM strategy that is customized to meet the digital and other transformation initiatives across clinical, safety, procurement, regulatory, commercial and other functions.
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An effective communications approach that is aligned with the change management plans and the specific needs of the client and their stakeholders / customers.
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A razor focused approach to ensure delivery of the transformation initiatives' expected outcomes.
Why Choose LS-SACS.com
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Highly collaborative - "Client Delight"
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Rigorous focus on "business outcomes"
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Achieve "real" transformation - "Run Better" and "Run Different"
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Progress from "Also Digital" to "Be Digital with AI"
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Establish operating models for "at office", "virtual" or "hybrid" work
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Open new markets AND translate "Mind Share" to "Market Share"
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"On-demand" expertise from an extended network of domain experts, technology leaders and SaaS partners