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

THE XTALKS BLOG

Clinical Research

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

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September 21, 2016 | by Lori Jones, Marketing Manager, Bioclinica

Investments in post-approval research are rising steadily year on year. Chances are, post-approval research represents a substantial part of a pharmaceutical, biotech, or medical device organization’s 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 how to reduce your post-approval research spend while simultaneously optimizing your study outcomes.

At the core of revolutionizing 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.

This blog post was originally published at: Post-Approval Research: Do You Have What It Takes?

How do you manage the challenges of post-approval research? Share your thoughts in the comments section below!



Keywords: Post-Approval Research, Randomized Controlled Trials, Real-World Data


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