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The Essential Role of Real World Evidence Combating COVID-19

Are you prepared for the necessary long-term tracking and follow-up?
Are you prepared for potential accelerated approval requirements?

Near the end of April, the FDA reported 72 active clinical trials for potential coronavirus treatments and an additional 211 programs in the planning stages. While these essential controlled interventional studies will yield gold standard evidence, the severity of the pandemic demands more than ever before that we turn to Real World Data (RWD) for rapid generation of insights into the safety and efficacy of the many licensed therapies being repurposed for treatment of the disease.

Manufacturers and regulators are turning to RWD to gain insight on COVID-19 natural history, expose correlations between treatments and outcomes, and obtain urgently needed data on the safety of these repurposed treatments. FDA Principal Deputy Commissioner Amy Abernathy recently commented on this concept by saying, “Within the context of COVID-19, we’ve got this urgency to learn what we can as soon as we can, and that means that we need to be learning from the patients that are receiving care right now and trying to understand how do we apply that as quickly as possible”.

There are three crucial ingredients needed to produce these vital insights:

  1. Epidemiological and data science expertise for designing and executing regulatory grade research
  2. A technology platform to support rapid and dynamic outputs including validated analyses
  3. Access to vast and representative sources of RWD

UBC is engaged in an intense initiative to harness the power of RWD to support health care providers, regulators, and manufacturers as they seek to optimize the management of patients being treated for COVID-19. We have partnered with industry leaders across the healthcare data landscape to assemble a compelling array of pharmacy and medical claims, laboratory and EMR data to deliver fit for purpose evidence to the life science community through a robust platform of automated analytics and custom study-specific validated outputs.

To learn more about UBC’s capabilities and expertise in accelerating COVID-19 evidence generation, get in touch with us today.

To read about the essential role real world evidence will continue to play into the future.

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Bekki Bracken Brown

President & Chief Executive Officer

Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.

With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.