Team of doctors consulting in a conference room

Medical Affairs Platform & Strategy

Our medical affairs solutions assist with developing and executing scientific and evidence generation and communication plans throughout the product life cycle.

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.

    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:

    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:

    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