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Powerful Post-Approval Operational Strategies for the 21st Century

Post-approval research studies are vastly different from pre-market studies designed for the registration of a new drug or device. In the white paper "One Size Doesn't Fit All": Applying an Innovative Mindset to Post-Approval Research, I outline these differences and illustrate why companies ought to leverage strategies, processes, standard operating procedures (SOPs), and technologies that are specifically designed for and more relevant to post-approval research.

As stated above, post-approval research studies are vastly different from pre-market studies. For instance, post-approval research studies may:

  • Be massive in sheer size and scope, requiring flexible and scalable resources.
  • Have less restrictive inclusion/exclusion criteria, permitting all patients to be included in the study.
  • Be under tremendous performance pressure to ensure return on investment (ROI), yet contend with cost constraints and tight budgets.
  • Involve research-naïve physicians as well as experienced clinical research investigators, requiring more training and administration to maintain engagement.

For all these reasons and many more, post-approval research (Phase IV) studies should not be conducted with the same strategies and approach used in pre-market studies. Unfortunately, they often are. This leads to inappropriate study design and execution, unnecessary processes, and increased resource requirements. The final result is that budgets are inflated and studies quickly become cost-prohibitive.

In the white paper "One Size Doesn't Fit All": Applying an Innovative Mindset to Post-Approval Research, you will discover how to:

  • Get the greatest return on your post-approval research investment
  • Adopt a mindset aligned with the unique needs of post-approval research
  • Use post-approval-specific technology to streamline Phase IV study operations and decrease costs

The benefits to adopting post-approval-specific strategies are unquestionable: you can increase patient compliance and data collection by 25-30% compared to traditional PRO technologies, and generate 15-20% overall cost savings on programs.

Discover how to claim these benefits for your company by downloading the white paper now.

Conducting post-approval research requires a unique mindset and specialized infrastructure.  Do you have what it takes?


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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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