Life Sciences Advisory & Support Services

Baker Tilly’s life sciences advisory and support practice provides clients guidance and solutions to address the unique needs that arise throughout all stages of the business and product life cycle. From market access strategy and planning to creating an effective compliance and ethics program, our team of professionals are here to help.

    Our solutions

    At Baker Tilly, our life sciences, medical device, pharmaceutical and biotech industry specialists help companies at all stages of their product and business life cycle. Whether it’s formulating a market access strategy or ensuring your company has an acceptable number of controls to mitigate risk, we are here to help.

    Translating data and research to address a population’s specific need as well as navigating the unique demands of health plans, healthcare providers (HCPs) and patients is a complex exercise. At Baker Tilly, we help address all angles of bringing a product to market and having it be accepted by patients, physicians and health plans through our comprehensive set of solutions, including:

    Market access strategy and support

    Our market access strategy and support services assist companies in executing evidence generation plans, analyzing market intelligence and pricing strategy, and facilitating payer outreach communication.

    Real-world evidence (RWE) generation

    We have direct access to nationally recognized real-world data (RWD) to generate reliable evidence and understanding about the economic and clinical outcomes of products.

    Whether you are an emerging life sciences company bringing your first product to market or are an established company with multiple therapies, our team can help you navigate through the commercial and medical needs of your product and business.

    Commercial enablement

    Our services help companies navigate through the entirety of the commercial enablement process for new and existing products through our pre-commercial assessment, field execution optimization and demand creation solutions.

    Medical affairs platform and strategy

    Our medical affairs solutions help life sciences companies develop and execute scientific and evidence generation as well as communication plans throughout the product life cycle.

    • Philanthropy and external funding program design and support: To further generate and communicate clinical knowledge to stakeholders and patients, our team is able to tap into our established relationships with external organizations to further support the value of life sciences products and their philanthropic strategies.
    • Patient support and advocacy: To better engage with patients and caregivers, our team can help build and design patient support programs as well as assist with outreach and funding support.
    Supply chain resilience

    When becoming more flexible and responsive to deal with unplanned disruptions becomes essential, as was experienced during the coronavirus pandemic, our team is able to help. We assist companies mitigate risks by evaluating supply chain strengths, correcting weaknesses and realigning operations to support the business’s strategic objectives.

    • Value-based contracting (VBC): Our professionals — that span across the healthcare ecosystem of life sciences companies, healthcare providers and payers — understand the complexities of transitioning, establishing and managing VBC arrangements. Our team can help life sciences companies begin their value-based journey through organizational awareness and education, feasibility studies, and contract design, enablement, and monitoring.

    There is no question that life sciences companies and their executives face the fear, uncertainty and doubt of identifying, isolating and measuring risk. At Baker Tilly, our team understands the necessity of having the proper governance and controls to protect the value of your brand, and we have the solutions to further minimize these risks.

    Enterprise risk management (ERM)

    Baker Tilly provides ERM solutions tailored to life sciences organizations at each stage of evolution while considering each phase’s unique resource and risk management needs.

    Internal audit

    Our internal audit solutions help life sciences companies monitor changes in organization processes, manage internal controls, ensure quality and mitigate risks associated with commercial, medical, safety, quality, regulatory, and government pricing and contracting activities.

    Investigations and litigation support

    Our team of life sciences and litigation support specialists help our clients minimize litigation risks and navigate complex dispute resolutions.

    Third-party risk management and due diligence

    Through evaluating third-party relationships, we are able to help life sciences companies conduct their required due diligence to ensure compliance with global anti-bribery and corruptions laws.

    Data privacy and protection

    Baker Tilly’s customized data privacy support solutions helps companies protect the personal information of their employees and clients, comply with federal and international privacy regulations, and develop privacy protocol and checklists in case of a cyber breach.

    Life sciences companies operate in a heavily regulated environment that also has intense public scrutiny. To help further protect the value of life sciences products and corporate brands, our team of compliance and ethics specialists work with clients to ensure they are operating in accordance with local, federal and international regulations, and that they are doing so with integrity.

    Compliance and ethics

    Our team of professionals provides a comprehensive set of solutions to solve your most pressing compliance and ethics needs across all facets of life sciences organizations, including

    • Compliance risk and needs assessments: Our team helps clients identify risks across their organization and provides a customized approach to ensure identified risks are mitigated based on the unique needs of the company.
    • Compliance auditing and monitoring: After risks are identified and mitigated, our team helps companies establish robust auditing and monitoring programs that provide insight into the ever-evolving compliance landscape of the life sciences industry.
    • Drug price transparency and reporting: Baker Tilly’s life sciences practice helps clients navigate the increasingly complex state and local price transparency and reporting environment through our pricing strategy, price reporting and transparency services.
    • Global spend transparency reporting: Our team assists companies understand the environment of spend transparency reporting to help ensure complete, accurate and timely compliance with reporting obligations.
    • Fair market value (FMV) and key opinion leader (KOL) tiering: Baker Tilly’s life sciences practice provides valuation and tiering services to determine the fair market value of payments to physician consultants, managed markets programs, medical grants and payments for clinical trials through our premier fmvNOW self-service application.
    • Quality management and pharmacovigilance: Our team is able to help life sciences companies ensure the ongoing safety of their products, including identifying, assessing, monitoring, preventing and reporting of adverse product effects to health authorities.

    We get it

    Effectively establishing and sustaining the value of your innovative research, therapy or drug is a difficult undertaking. What complicates this even more is the fear, uncertainty and doubt that can be caused by:

    • Complex and evolving regulations impacting all business operations
    • Risk overload by executive teams that find it difficult to identify, isolate and measure concern
    • Changing expectations from patients, payers, healthcare providers and regulators controlling market access
    • Specialty market commercialization and navigating greater patient needs that have more complex barriers to access

    We understand the complexities of not only bringing a product to market and establishing a commercial function for your organization, but also mitigating these complex risks and making sure your business is operating with integrity and in accordance with regulations.