Tuesday, 31. March 2020 18:15

SAN DIEGO, March 31, 2020 (GLOBE NEWSWIRE) -- PHASTAR is pleased to announce our second webinar of 2020, one of several planned throughout the coming year that will explore and provide insights into the critical aspects defining today’s clinical trials.  For example, increasing volumes of real world evidence (RWE) are being produced following the development of specialist devices and data collection techniques.  Dr. LaRee Tracy, PHASTAR’s Director of Biostatistics, will delve into the regulatory aspects of RWE as it relates to the U.S. Federal Drug Administration’s framework on RWE mandated by the 21st Century Cures Act. 

WHAT:  “Reality Check – Ideas and Trends in Real World Evidence – From a Regulatory Perspective”

WHEN:  Wednesday, April 8, 2020 at 4 p.m. EDT/1 p.m. PDT

WHERE:  Click here to register:  ‘ideas and trends in real world evidence from a regulatory perspective’

LEARNING OBJECTIVES:  This webinar will discuss current concepts of real world data and real world evidence and summarize the U.S. Food and Drug Administration’s framework on Real World Evidence mandated by the 21st Century Cures Act.  The webinar will also highlight recent regulatory approvals in which real world evidence was relied upon in the evaluation of product safety and effectiveness. 

ABOUT DR. TRACY:  Dr. LaRee Tracy is PHASTAR’s Director of Biostatistics and leads the company’s San Diego office.  The office serves as a strategic operational hub to support PHASTAR’s west coast customers and is a key component of the company’s current 5-year growth plan.  Dr. Tracy brings more than 24 years of experience in clinical research, industry regulation and clinical operations, including over 16 years as an FDA CDER.

PHASTAR is a global CRO offering statistical consulting, clinical trial reporting, data management and data science services by providing expert consultants and managing and delivering in-house projects, FSP style arrangements and preferred partnerships. PHASTAR’s number one priority is to ensure that the work we produce is of the highest quality. Every project PHASTAR undertakes utilizes our unique internal processes which are designed to ensure optimal quality. 

All PHASTAR’s statistical, programming and data management staff are trained in the “PHASTAR Discipline” - our in-house approach to data analysis and collection. This comprises a set of common sense (but commonly ignored) principles that, if followed, guarantee error free outcomes. The “PHASTAR Discipline” also includes a series of intranet-based checklists highlighting potential pitfalls and points-to-consider when conducting clinical trials, enabling over 3,000 years of combined technical knowledge to be shared across the company.

Media Contact:
Dawn Fontaine
Ripple Effect Communications

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