S3: E2 Centralized Monitoring in Action: Case Studies From the Field
On this week’s episode, host Sophia McLeod is joined by Danilo Branco (Associate Director, Risk Based Quality Management Lead, BeOne Medicines) and Amanda Coogan (Associate Director, Customer Experience, Remarque Systems) to discuss the value of centralized monitoring implementation by sharing case studies from today’s clinical trials. They dive deeper into how centralized monitoring can help detect adverse events more quickly and identify underreporting, the benefits of holistically monitoring trial data using centralized monitoring, and how a targeted SDV/SDR sampling strategy can help organizations to conserve resources while maintaining quality and safety.
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Special Episode: 2025 State of the Industry
On this special episode of ACRO’s Good Clinical Podcast, 2025 ACRO Chair Jim Reilly (Veeva) and Vice-Chair Sandy Kennedy (Fortrea) join the podcast to discuss the current state of the clinical research ecosystem and where our industry should focus attention to continue moving research forward in 2025.They dive deeper into the challenges and opportunities in making clinical research more accessible globally, the benefits of standardization in research, how our industry relationship with sites must evolve, and the positive impact that more representative trials have on data quality.
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Special Episode: RBQM: A Case for Centralized Monitoring
This week, ACRO’s Good Clinical Podcast returns for a special episode! Lauren Garson (Veeva), Nicole Stansbury (Premier Research) and Jennifer Stewart (Premier Research) join the podcast to discuss the ACRO RBQM Working Group’s latest paper, “Risk-based Quality Management: A Case for Centralized Monitoring," available to download at https://www.acrohealth.org/resource/rbqm-centralized-monitoring/They dive deeper into highlights from their latest publication, including the benefits of a risk-based approach to trial monitoring and the role that centralized monitoring can play in building more efficient and effective clinical trials.
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21:46
S2: E4 Pediatric Clinical Trials: Compassion in Action
On this episode, Susan McCune, MD (VP, Pediatrics & Clinical Pharmacology, The PPD Clinical Research Business of Thermo Fisher Scientific) and Jacqui Whiteway, PhD (Senior Director & Pediatric Strategy Liaison, Center for Pediatric Clinical Development, ICON plc) join the podcast to discuss what makes pediatric clinical trials unique and how industry can make participation easier for pediatric patients and their families.They dive deeper into the role that compassion plays in designing successful trials, the importance of including pediatric patients and families in trial protocol design, and creative tools to boost patient engagement
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S2: E3 ICH E6(R3): The Thinking Person's GCP
On the latest episode of ACRO’s Good Clinical Podcast, Nicole Stansbury (SVP, Global Clinical Operations, Premier Research) and Madeleine Whitehead (RBQM Product & People Lead, Roche) join the podcast to talk about ACRO’s collaboration with TransCelerate BioPharma, Inc. and to discuss impact that ICH E6(R3) will have on Good Clinical Practice and implications for innovation.They dive deeper into the benefits of a risk-based approach, regulator’s thoughts making clinical research more agile, and the potential to help industry bring medicines to patients more efficiently.
ACRO’s Good Clinical Podcast dives into topics vital to driving innovation in clinical research, from AI and other cutting-edge technology to regulatory topics that impact clinical trials around the world. ACRO's Sophia McLeod is joined by leaders from across the drug development industry to discuss the latest trends and what direction the industry must head to continue improving trials for patients
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