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Compliance Auditing & Monitoring

Baker Tilly life sciences helps its clients address identified areas of risk across the organization through the design and execution of robust auditing and monitoring programs

While it is important to take a detailed look at traditional areas of risk, it is equally important to know what is coming around the corner. Our clients rely on us to protect their value through the design of effective auditing and monitoring programs, methodologies and procedures in order to provide insights into what is next in the ever-evolving compliance landscape.    

    Government regulators have made it clear they want life sciences companies to be proactive in addressing areas of non-compliance in their organization. The first step in addressing non-compliance is to identify it.

    As such, government bodies have dictated that life sciences, medical device and pharmaceutical organizations need to have a robust auditing and monitoring program in place.

    The life sciences industry is constantly being bombarded with new and evolving regulatory guidelines, laws and subsequent enforcement actions. It is imperative that companies remain current on their legal and regulatory obligations and proactively address these areas of risk ahead of any government investigation or action.

    Compliance Monitoring

    No matter how much preparation, training and documentation we do, there is still a high level of uncertainly related to the question: “Do we really know what is going on out there”?  Compliance Monitoring is the most effective way to address that fear, uncertainty and doubt. Since it is performed in real time, monitoring allows you to continually assess the health of the compliance program on an ongoing basis. Continuous monitoring can take the form of transaction/paper based monitoring as well as in-person “live” monitoring of specific activities. 

    Baker Tilly has independent, scalable compliance experts that help in execute on your compliance monitoring needs.

    Supporting monitoring needs

    At Baker Tilly, our Life Sciences Consulting team supports our clients’ transactional and live monitoring needs for risk areas across the organization, including, but not limited to, the following:

    •  Speaker programs
    • Advisory boards
    • Medical education programs
    • Expense reports
    • Social media
    • Patient influencers
    • Conferences
    • Email and call notes
    • Global payments for bribery and corruption
    • HCP screening
    • Field ridealongs
      – Sales representatives
      – Medical science liaisons
      – Patient advocacy specialists
      – Account managers
      – Managed care specialists

    Our focus on value protection means we remain engaged with our clients to support their ongoing auditing and monitoring strategies.