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Monday, June 20 • 1:15pm - 2:15pm
#109: Risk-Based Monitoring in Clinical Trials: An Evolution of Practices During the COVID Pandemic

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-512-L04-P ; CME 1.00; RN 1.00

The industry embraced an enormous shift during the global pandemic. This panel will report out on a two-year analysis conducted on over 6,000 clinical trials. We looked at the study-level and surveyed how risk-based and approaches are being adopted

Learning Objectives

Describe how risk-based approaches are being used in the industry, and how adoption shifted during the pandemic; Identify components that are being underutilized (e.g., centralized monitoring) and discuss potential benefits of adopting them; Explain how your organization can benefit from taking a risk-based quality management approach to every study

Chair

Brian Barnes, MA

Speaker

Panelist
Nicole Stansbury

Panelist
Paula Jo Butler, MA

Panelist
Lauren Garson

Panelist
Jennifer Glonke Stewart, MBA


Speakers
avatar for Brian Barnes

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States
Brian has 17 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Association of Clinical Research Organizations (ACRO) RBQM... Read More →
avatar for Paula Butler

Paula Butler

Senior Director, Operational Transformation and Performance (OTP), IQVIA, United States
Paula Jo Butler has over 35 years of experience in the Clinical Research Industry serving roles within Biostatistics and Project Management. She is currently IQVIA’s Senior Director of Operational Transformation and Performance (OTP). Her leadership experiences include oversight... Read More →
avatar for Lauren Garson

Lauren Garson

Senior Director, Clinical Strategy, Veeva Systems, United States
Lauren joined Veeva in 2018 and is a Sr Director in the Vault Clinical Operations Strategy team. She is responsible for Vault eTMF, SSU, CTMS and Payments for Enterprise level customers and is the lead strategist for Vault Risk Based Study Management. She is passionate about ensuring... Read More →
avatar for Nicole Stansbury

Nicole Stansbury

VP, Global Clinical Trial Management, Syneos Health, United States
Nicole Stansbury, Vice President, Clinical Trial Management, joined Syneos Health in February 2019 and is responsible for global clinical trial management and monitoring strategy. Prior to leading the global CTMs at Syneos, Nicole led the Global Central Monitoring team and risk -based... Read More →
avatar for Jennifer Stewart

Jennifer Stewart

Executive Director, Clinical Data Sciences, Premier Research, United States
As Executive Director, Jennifer Stewart coordinates the efforts of Premier Research’s global Clinical Data Sciences department, offering expertise in clinical data management and data surveillance. She plays an active role in corporate initiatives for improving quality, efficiency... Read More →

Monday June 20, 2022 1:15pm - 2:15pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   08: RD Quality-Compliance, Forum
  • Level Intermediate
  • Featured Topics COVID-19
  • Level Intermediate
  • Feature Topics COVID-19
  • Credit Type ACPE, CME, RN
  • Tags Forum