What can CROs do better?

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Description of event:

This PCMG Insights session will explore how objective assessment of Clinical Research Associate proficiency can support monitoring oversight and workforce development in clinical trials.

Gerald DeWolfe will discuss the use of monitoring visit simulation to evaluate CRA knowledge, skills and abilities, drawing on experience assessing more than 8,500 CRAs across 70 countries since 2013. The session will consider what this type of simulation-based evaluation can show about CRA proficiency, including variability across role titles and years of experience.

The webinar will also look at how structured assessment data may help organisations identify development needs, support CRA improvement, and provide evidence to support monitoring oversight expectations under ICH E6 (R3).

Key discussion points

• Objective evaluation of CRA knowledge, skills and abilities
• What simulation-based assessment can show about CRA proficiency and variability
• How structured assessment may support CRA development
• How assessment evidence may support ICH E6 (R3) monitoring oversight expectations

Learning objectives

By attending this session, participants will be able to:

• Understand how monitoring visit simulation can be used to assess CRA proficiency
• Recognise how CRA capability may vary across titles and years of experience
• Consider how assessment data may support CRA development and monitoring oversight under ICH E6 (R3)

Who should attend

This webinar is relevant for professionals involved in clinical monitoring, clinical operations, outsourcing, vendor management, quality oversight and CRA development within pharmaceutical, biotech and medical device companies.

CRA Assessments provides the only comprehensive and objective monitoring visit simulation to evaluate CRA knowledge, skills, and abilities in the industry. We have evaluated over 8,500 CRAs in 70 countries since 2013. Data shows CRA proficiency is significantly below desired/expected and there is extreme variability even within CRA titles/years of experience. We can provide extensive data to show improvement when completing our development process. Companies can use this tool to support ICH E6 (R3) monitoring oversight requirement.

Speaker:
Gerald DeWolfe
CEO and Founder, CRA Assessments

With over 25 years in clinical research, Gerald DeWolfe is the CEO and Founder of CRA Assessments, a company providing innovative web-based simulations to objectively and comprehensively evaluate Clinical Research Associate proficiency. Drawing on previous CRO experience at Covance, INC Research, and PPD, Mr. DeWolfe’ s focus is on advancing quality oversight, operational excellence, and  workforce development in clinical monitoring.