Life Sciences Consulting

Answering critical business questions for successful commercialization.

Today’s life sciences commercial market environment demands that biopharma companies establish and demonstrate portfolio and asset value early in the development lifecycle through launch.

With an unmatched legacy in strategic launches, our Commercial Advisory team’s industry expertise and predictive business intelligence approach offers insights that ensure optimal market positioning, recalibrating strategies in response to market shifts, and enhancing decision making. 

We hold deep development and launch expertise and leverage our data- and analytics-driven strategic insights to maximize overall asset and portfolio value by navigating key strategic questions: 

• Where and how should we invest for long-term value creation? 
• What innovative development strategies will maximize asset value while accelerating speed to market, reducing development risk, and maximizing the commercial potential? 
• How should we prepare our asset and organization to commercialize successfully? 
• How do we cultivate an unparalleled customer experience with the brand and organization? 

Our project offerings include:

Portfolio Strategy

• Growth Strategy
• Asset Search and Screen
• Opportunity Assessment
• Buy and Sell Side Diligence

Product Development Strategy

• Indication Prioritization
• Winning Label / Target Product Profile Optimization
• Clinical Development Strategy and Planning
• Protocol Optimization
• Virtual Program and Diligence Teams

Product and Franchise Strategy

• Launch Strategy and Planning
• Strategic Marketing Assessments (e.g., Patient Journey, Segmentation)
• Brand Acceleration and Lifecycle Management
• Marketing and Launch Excellence

Customer Strategy

• Field Force Design
• Customer Engagement Strategy
• IDN Strategy and Implementation
• Key Account Management Optimization

Developing innovative strategies for R&D transformation and operational excellence

Working directly with customer CD&O, Clinical Data Management, Regulatory, Quality, and PV business functions for both small biotech and mid-to-large biopharma companies, we utilize a Diagnose-Design-Deploy methodology to drive transformation across the R&D enterprise.

Our project offerings include: 

Strategy Consulting 

• Operating Model Transformation: Benchmarking, designing and implementing R&D functions’ strategy, organizational architecture and capability frameworks to drive productivity and innovation.
• Patient & Site Engagement: Benchmarking current activities andimplementing frameworks to drive improved outcomes and relationships.
• DE&I: Providing strategies and methodologies to support diverse involvement in clinical trials and across clinical development.
• Support to Biotechs: We provide R&D infrastructure build to biotechs bringing their first assets through development.

Business & Technology Consulting 

• Technology Strategy: Assessing R&D systems and data to enhance and accelerate clinical development. 
• System Implementation:Supporting implementation and adoption through business process redesign, change management, training and benefit realisation. 
• Data Science & AI: Crafting DS&AI strategies, building business cases, and scaling innovation. 
• Business Process Engineering: Optimizing clinical development processes for efficiency and compliance. 

Developing strategies to achieve optimal performance, greater value creation, and enhanced patient outcomes.

Our global Medical Affairs team is focused on strategy and execution, leveraging cross-functional expertise to design tailored solutions that aim to support organizational transformation and asset, portfolio, and therapeutic area strategic engagements, driving positive perception of clinical, economic, and patient value.

Our project offerings include:

Organization Transformation:

• Organizational benchmarking and strategy to optimize scientific communications, evidence general and external engagement
• Value demonstration and impact measurement
• Capability/competency assessment, development and resource planning

Operational Optimization:

• Process modeling and mapping to analyze current workflows and identify the efficient operational model design that best aligns with organizational goals
• Knowledge management to streamline the organization and dissemination of important scientific data, insights and communications
• Quality management design including KOL Governance Frameworks

Product & Asset Strategy:

• Medical launch strategy and planning
• KOL mapping and identification
• Medical stakeholder engagement strategy
• Training for field team excellence

Evidence Generation and Dissemination Strategy:

• Integrated evidence strategy
• Investigator-initiated studies and collaborative research support
• Publication planning, congress and omnichannel strategy

Clinical Trial Acceleration:

• Research Science Liaisons (RSLs) for early engagement, accelerated study activation and risk mitigation via close collaboration with clinical operations staff
• Patient, KOL and site engagement to accelerate clinical trial protocols to meet both patient and expert expectations.

Delivering HEOR evidence using robust & payer-preferred methods

HEOR evidence is crucial for drug reimbursement decisions. To ensure successful product development and commercialization, timely and relevant evidence must be available to key stakeholders.  

We partner with you to create customized solutions tailored to your product’s needs throughout its lifecycle.  

We provide comprehensive services that blend technical expertise with strategic insight, including:

• Literature review and synthesis: Systematic literature review, Targeted review, Network Meta-Analysis, Indirect Treatment Comparison
• Economic modeling: Cost-Effectiveness Model, Budget Impact Model, Forecasting model, Contracting tool
• Data analysis: Analysis of Health-care retrospective EMR/claims data, Analysis of Patient Level Data
• Dossier: Local HTA dossier, Global Reimbursement Dossier, Global Value Dossier
• Evidence dissemination: Manuscript development, Abstract and poster for scientific conferences
• HEOR strategy: Trial design optimization, Gap analysis, Evidence generation plan, HTA advice

Developing payer strategies and tactics that capture the value of your product and pave the way for commercial success

As pharmacy budgets increase, global payers’ ability to control access stronger every year. We integrate powerful data, global payer viewpoints and best-in-class leadership experience to capture the full value of your innovation.   

We focus on three fundamentals:

• Assessing the market access landscape: Leveraging powerful data and analytics services combined with direct payer insights, our team evaluates market position and forecasts the access environment an innovator will encounter. 
• Identifying product value: With comprehensive clinical and economic viewpoints, we describe an innovation’s value, formulate evidence plans and structure pricing strategies for payers globally. 
• Delivering innovation to patients: With expertise in complex therapeutic areas, we ensure patient fulfillment through the right distribution model and the right partners. 

Designing, developing and implementing large-scale programs and broad transformation initiatives

Our Risk & Program Management (RPM) advisory team comprises experienced strategic project managers and risk management professionals who will partner with you to navigate the complex nuances of the healthcare and biopharma industries.

We support the development, implementation, and management of large-scale programs and broad transformation initiatives including:

• Post-marketing risk management and commitments
• Multi-sponsor programs
• REMS
• Global risk management plans
• FDA advisory committee meetings
• Conferences and events 

Our customers also benefit from our insights regarding KAB surveys, assessments, and analytical services. 

Our experienced Quality & Compliance team can assist with proactive planning to ensure compliance across systems and projects or respond to immediate needs. Our experience with compliance assessments has a global span and includes all phases of research from product development through clinical and post-marketing.  

The Quality & Compliance Advisory is a completely independent team within Syneos Health, comprised solely of senior-level auditors/consultants with an average of 15 years of regulatory experience encompassing GCP, GMP, GVP and GLP.  The knowledge of this highly experienced team spans every auditing requirement, regulation type and market, facilitating global QA consistency and allowing us to tailor each auditor to each audit/quality need for maximum results.  We offer flexible partnership models (e.g., stand-alone audits and FSP approaches) to meet your needs.

From total QA program management to individual site audits, we offer a comprehensive set of services including but not limited to: 

• Investigator site audits 
• Mock inspections and investigator site audit preparedness training  
• Pharmacovigilance/safety audits 
• Vendor qualification and performance audits
• Data management and biostatistics audits 
• Manufacturing site Audits 
• Trial master file audits
• Document audits 
• GMP, GLP, GCP, GVP process audits 
• Computer system validation audits 
• REMS Audits 

From a Global QA perspective, we also provide support on the implementation of a robust QMS which fulfills industry standards and ensures inspection readiness. We have expertise in conducting gap analysis, detecting areas of improvement and provide full writing, editing and technical expertise on the creation of procedures and their subsequent implementation. We can support the process’s definition and optimization and act as compliance advisor at all development stages. These services are customized to your exact needs at any point in your development cycle.