Medical Affairs Platform & Strategy
Medical Affairs Platform & Strategy
As the medical affairs function transitions from a support function to its new purpose as a primary strategic pillar, life sciences and medical affairs organizations are being asked to further bridge the scientific gap by generating and communicating clinical knowledge to stakeholders and patients.
Helping protect and enhance your company’s value
Mitigating the growing numbers of risks of post-approval activities has many hurdles and is a critical task for life sciences companies. Furthermore, organizations require results-proven professionals to develop a strategy that aligns medical affairs activities with core business goals and that is supported by real-world evidence (RWE).
At Baker Tilly, our experienced life sciences industry specialists have foresight into the future state of medical affairs and provide the strategic lens that medical device and pharmaceutical companies need to achieve success now, and for tomorrow. Our specialized professionals understand the intricacies of navigating the complex demands of physicians, hospitals and hospital systems, and health plans to help organizations disseminate accurate and effective information on product value. These solutions take into account compliance and accreditation standards, key opinion leader (KOL) management, medical information and education, and evidence generation in developing comprehensive medical affairs strategies.
Our approach
Baker Tilly’s medical affairs strategy and enablement services assist companies in balancing clinical communications with novel evidence generation. Thoughtful program design and execution enables our clients to sustain market penetration from launch through the product lifecycle. Our approach includes:
- Assessing opportunities for optimization, innovation and evidence generation
- Communicating clinical and educational information
- Managing relationships with KOLs
Our solutions
Baker Tilly’s focus is on our medical affairs solutions that are derived from data-driven insights that help mitigate some of the largest risks to medical affairs success. Our team offers a comprehensive set of solutions to help our clients and to achieve their medical affairs goals.
Baker Tilly helps companies improve the implementation of key activities to increase efficiency and reduce time, resource wastage and mistakes, including:
- Evaluating and reducing cross-departmental inefficiency and redundancy
- Operationalizing organization structure and vision to align with corporate goals
- Developing and implementing qualitative and quantitative strategies to measure and monitor budget and goals
- Optimizing technology infrastructure of life sciences companies and manufacturers for functionality and user-experience
- Developing comprehensive information technology, social media and mobile health technology strategy
Our deep understanding of compliance assists life sciences companies with their effort to remain compliant with local, federal and global regulatory bodies throughout the product life cycle, including:
- Proactively maintaining compliance with, and readiness for, anticipated and future government regulations
- Conducting compliance risk assessment and auditing
- Optimizing the functionalities related to safety, quality, and compliance monitoring and response activities
- Designing and implementing risk evaluation and mitigation (REM) strategies and corporate compliance and ethics programs
- Implementing comprehensive accreditation needs assessment and strategy development in collaboration with the Accreditation Council for Medical Affairs (ACMA)
Our experience enables life sciences companies to develop and implement systems to more effectively assess and manage investigator initiated trials (IITs), including:
- Optimizing and developing infrastructure to evaluate requests to conduct clinical research
- Building systems to manage ongoing external clinical research and assisting with regulatory compliance and timelines
- Developing strategies to assist with IITs alignment with established clinical findings and analytic rigor, while also generating novel outcomes
- Managing IIT strategy and implementation
Our deep industry relationships uniquely enable us to connect life science companies with industry leading KOLs and develop mutually beneficial collaborations, including:
- Identifying and tiering of local and global KOLs
- Establishing and managing KOL relationships to assist with quality and compliant collaborations
- Developing KOL thought leadership content
- Managing thought leader strategy and implementation
We have experience assisting life sciences companies comply with local, federal and global regulatory bodies throughout the product life cycle and help companies through:
- Identifying product knowledge gaps in the literature
- Developing and implementing publication strategies
- Effectively communicating clinical and economic findings to non-medical audiences
With our wide range of experience, we help life sciences companies more efficiently and effectively store, disseminate and monitor their medical information, including:
- Designing and optimizing medical information libraries for improved user experience
- Optimizing medical information delivery systems
- Evaluating and optimizing medical science liaisons (MSLs) marketing collateral based on audience needs
- Developing strategic key performance indicators (KPIs) and benchmarks to assess MSL performance
- Assessing and optimizing cross-functional activities with sales, research and development (R&D), and clinical departments
Our knowledge of care pathways enables us to help life sciences companies develop a well-rounded view of how and where patients receive treatment, including:
- Developing a comprehensive understanding of the patient- and therapeutic-specific care pathways
- Identifying strategic locations for treatment delivery improvement along the pathways
- Developing process and outcome metrics to assess hospital and health system performance
- Enhancing support and management services along the pathway to improve patient care delivery
Our deep analytical experience helps life sciences companies generate meaningful RWE to demonstrate value and expand product use, including:
- Designing RWE and health economics and outcomes research (HEOR) studies and innovative analytic models to document “product value”
- Creating metrics using innovative measures to demonstrate value to external stakeholders
- Supporting organizations to maximize value of evidence through identification of expanded indications, populations and markets for product/therapy
- Evaluating cross departmental roles to reduce miscommunication and redundancy
- Developing strategic qualitative and quantitative tactics to measure and monitor goals
- Identifying novel candidate segments to widen market penetration
- Developing pre- and post-approval product plans and strategies
Through our deep understanding of the needs of life science research driven by external partners, we help life sciences companies establish and maintain mutually beneficial relationships with external organizations to support product value, including:
- Identifying key industry associations, academic medical centers and patient advocacy organizations
- Establishing and optimizing mechanisms to use IIT data to support clinical decisions for unmet medical needs
- Developing and implementing strategies to maintain external relationships to improve body of evidence supporting product value