Clinical operations and drug safety organizations continue to be challenged to operate more effectively and efficiently in a dynamic business environment. Proper planning, execution and effective use of the latest technology is essential.


Organizations must constantly balance stability with ingenuity as they work to stay current with ongoing regulatory changes, reduce overall operating costs and offer solutions that drive efficiencies. Advancements in clinical and safety applications, platforms and technologies offer biopharmaceutical organizations the opportunity to address current and future business challenges while improving operations.

Having a long term strategy and roadmap, as well as the ability to execute, is crucial for any organization to remain competitive.


In today’s ever changing market, many factors influence clinical operations, including regulations, budget, product availability/upgrades, technology, product roadmaps and internal business dynamics (e.g., mergers, acquisitions, reorganizations).

The good news is that there are several solutions, platforms, vendors and technology advancements from which to choose. The organizations that can most effectively leverage these offerings will benefit and evolve rapidly to stay ahead of the curve.

How Baker Tilly can help

Baker Tilly continually monitors and prepares for advancements in clinical and safety applications, upcoming regulations and technology innovations which may benefit clinical operations.

Our clinical and drug safety professionals, along with our demonstrated methodologies, will help guide your organization through the process of developing long term strategic plans, selecting and implementing new solutions, performing upgrades, transitioning to the cloud or simply re-evaluating your existing systems and processes for improvements.


Baker Tilly focuses on the intersection where “Strategy meets Execution.”  We offer a full range of services designed to mitigate risks and help clients achieve their business goals.

Our demonstrated methodologies, structured approaches and deep industry experience will help you lower program risk, enable organizational change and optimize your business outcomes.

  • Operational and technical assessments for safety and clinical
  • Roadmap and strategic planning for safety and clinical
  • Project management and change management
  • Project health assessments
  • Enterprise cloud transformations
  • Systems implementation and upgrades
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Our Take

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“Baker Tilly brings proven methodologies and structured approaches to your Clinical and Safety Implementations. We can manage your projects, help minimize your risks and drive your projects to the desired business outcomes.”

— Mike Cavallo, Director, Life sciences/healthcare