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Post-Approval Research: Do You Have What It Takes?

Investments in post-approval research are rising steadily year on year. Chances are, post-approval research represents a substantial part of your annual budget. But how much of that money is being wasted by conducting post-approval studies in an inappropriate and inefficient manner?

Bioclinica's free webinar Conducting Post-Approval Research Requires A Unique Mindset And Specialized Infrastructure. Do You Have What It Takes? shows you how to reduce your post-approval research spend while simultaneously optimizing your study outcomes.

At the core of revolutionizing your post-approval research is understanding the fundamental differences in conducting research in pre-market randomized controlled trials (RCT) versus post-approval research. For example:

  • Post-approval research is performed to satisfy a wide variety of business needs – it is not simply about whether drugs are safe and effective (the primary goals of Phase I, II, and III clinical trials).
  • Post-approval research has a unique set of challenges, such as massive scope, research-naïve physicians, and lengthy time horizons.
  • Post-approval research is not subject to the same regulatory requirements demanded in pre-market RCTs.

If the differences between pre-market RCTs and post-approval studies are not appreciated, then post-approval research becomes burdened by unnecessary rigor, inappropriate design, and inefficient execution. This results in inflated costs and increased resource burn. Studies can quickly become cost-prohibitive.

In contrast, treating post-approval research for what it is – not as a modified Phase I, II, or III trial – streamlines the operational processes involved, reduces costs, and enhances outcomes. For example, a successful post-approval study will utilize:

  • A patient-centric methodology for the design and implementation of the study
  • SOPs that are specifically-designed to meet the objectives of the study
  • Smart technology to improve the flow of communication and contain study costs
  • Centralized remote monitoring to support sites and ensure regulatory standards are met
  • A flexible, scalable, customizable technological infrastructure geared for post-approval research

With the pressing need to obtain real-world data, assess product safety profiles, and support the full span of a product's lifecycle, the ability to conduct efficient, cost-effective post-approval studies is more important than ever.

View the webinar now to discover what it takes to conduct successful post-approval studies in today's complex pharmaceutical environment.

For more information on Bioclinica's post-approval research services, click here.

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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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