• How Clinical Research Hiring Decisions Are Actually Made with Giovanni Lauricella
    Apr 30 2026

    Why do qualified candidates apply to role after role in clinical research and never hear back?

    In this episode of the Clinical Trial Podcast, we unpack what's really happening behind the scenes in the hiring process.

    Because getting hired isn't just about your technical skills. It's about how hiring managers assess risk, how recruiters decide who to champion, and who actually gets attention versus who gets ignored.

    Kunal Sampat is joined by Giovanni Lauricella, Co-Founder and CEO of Lifeblood, an executive search firm specializing in MedTech. With over 15 years of experience placing board members, C-suite leaders, and cross-functional talent globally, Giovanni brings a unique perspective from inside the hiring process.

    In this episode, you'll learn:

    • Why strong candidates get filtered out before interviews
    • What hiring managers are actually looking for
    • How recruiters decide who to champion for
    • What it really takes to break into and advance in clinical research

    If you've ever felt stuck in your job search or wondered why the process feels like a black box, this conversation will give you a clearer understanding of how hiring decisions are actually made.

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    1 hr and 8 mins
  • Designing and Conducting Observational Studies with Thomas Newman, MD, MPH
    Mar 30 2026

    What separates strong clinical research from misleading conclusions?

    Often, it comes down to study design.

    In this episode of the Clinical Trial Podcast, Kunal Sampat sits down with Dr. Thomas Newman, Professor of Epidemiology and Biostatistics at UCSF and co-author of Designing Clinical Research, to break down how observational studies actually work.

    While randomized controlled trials are often considered the gold standard, observational studies are essential in many real-world settings. But they come with challenges including bias, confounding, and misinterpretation that can lead to flawed conclusions if not handled correctly.

    Dr. Newman shares a practical framework to help you design better studies, interpret results more critically, and build a stronger foundation in clinical research.

    In this episode, you'll learn:
    • When observational studies are more appropriate than randomized trials
    • A practical framework for designing observational research
    • Key threats to validity: bias, confounding, and chance
    • How to interpret associations vs. causal effects
    • Strategies for dealing with confounders in analysis
    • How to approach statistics with more clarity and confidence
    About the guest:

    Dr. Thomas Newman, MD, MPH, is a Professor of Epidemiology and Biostatistics at the University of California, San Francisco. His work focuses on applying epidemiologic methods to important clinical problems in child health, including neonatal jaundice, infections in newborns, and cholesterol screening.

    He is widely recognized for his contributions to clinical research education and is co-author of Designing Clinical Research and Evidence-Based Diagnosis.

    Why this episode matters:

    If you want to grow in clinical research, you need more than surface-level knowledge - you need to understand how studies are designed and where they can go wrong.

    This episode helps you think like a clinical researcher.

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    1 hr and 14 mins
  • Cardiovascular Device Development: From Idea to Reality
    1 hr and 37 mins
  • Best Practices for Clinical Trial Budgeting
    Jan 19 2026

    Clinical trial budgeting remains one of the biggest bottlenecks in study startups, driving delays, rework, and frustration across sponsors, CROs, and research sites.

    In this episode of the Clinical Trial Podcast, recorded live at Research Revolution, a clinical research conference hosted by Florence Healthcare, we take a hard look at why clinical trial budget negotiations continue to break down—and what experienced operators are doing differently.

    This conversation brings together sponsor, site, and consultant perspectives to unpack the real drivers of delay, including slow escalation pathways, unclear or inconsistent budget justifications, misaligned expectations, and communication gaps between stakeholders.

    Rather than rehashing theory, this episode focuses on practical, experience-driven insights you can actually apply.

    In this episode, you'll learn:

    • The most common causes of delays during clinical trial budget negotiations
    • How sites can create clear, defensible budget justifications without triggering endless revision cycles
    • What sponsors look for when approving higher-than-expected line items
    • Best practices for internal rate cards, fee schedules, and budgeting templates
    • How improved communication and transparency can reduce negotiation friction and speed study startup

    This episode features insights from:

    1. Kristen McKenna, Senior Manager and Investigator Contracts Lead at Pfizer
    2. Heidi Castle, Director of Business Development at Mercy Research
    3. Matt Lowery, CEO and Principal Consultant at The Pathways Group

    If you're involved in clinical trial budgeting, contracting, or study startup - whether at a sponsor, CRO, or research site - this episode offers practical insights to help you navigate negotiations more effectively and avoid common pitfalls.

    Listen to the episode to hear how sponsor, site, and consultant leaders approach clinical trial budgeting and study startup.

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    48 mins
  • Risk Based Monitoring in Clinical Trials with Artem Andrianov
    Dec 31 2025

    Risk-based monitoring has been discussed in clinical research for more than a decade, yet many organizations still struggle to implement it in a meaningful and effective way.

    In this episode of the Clinical Trial Podcast, we sit down with Dr. Artem Andrianov, a leading expert in clinical data quality and risk-based quality management, to unpack what risk-based monitoring really means in today's regulatory landscape.

    Artem has over 25 years of experience in the pharmaceutical industry and is the CEO and cofounder of Cyntegrity a company that specializes in data driven risk management in clinical trials.

    Together, they explore how the industry has evolved from traditional monitoring approaches to a more holistic model centered on risk-based quality management and quality by design.

    Dr. Andrianov shares practical insights on common misconceptions, why simply reducing monitoring is not a strategy, and how technology and analytics can be used to proactively manage risk.

    The conversation also examines the changing role of CRAs, and the growing expectations from regulators and inspectors.

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    1 hr and 20 mins
  • Leading a Clinical Research Organization in the European Union with Dr. Philip Raeth
    Dec 15 2025

    In this episode of the Clinical Trial Podcast, host Kunal Sampat sits down with Dr. Philip Räth, Managing Director of Palleos Healthcare, to discuss leading Clinical Research Organization (CRO) in the European Union (EU).

    Managing a Clinical Research Organization is far more than project oversight. CRO leaders juggle sponsor expectations, site relationships, internal talent, regulatory demands, and profitability. A strong CRO partner can jumpstart a clinical trial for industry or academic sponsors that have limited infrastructure. A mismatched CRO, on the other hand, can derail timelines, add cost, and create friction you don't need.

    About Today's Guest: Dr. Philip Räth

    Dr. Räth brings 15 years of experience in the medical product industry and currently leads Palleos Healthcare, a central European full-service CRO supporting pre-clinical consulting through large-scale clinical trials.

    Operations in 19 countries
    336+ projects delivered
    Expertise across 23 therapeutic areas

    In this episode, you'll learn:

    What makes a CRO truly sponsor-ready

    Where CRO selection often goes wrong

    How digital transformation and AI are reshaping CRO operations

    Insights from Palleos' work across Europe and diverse therapeutic areas

    The future of full-service clinical trials from a CRO leader's perspective

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    1 hr and 16 mins
  • Sponsor, Site, and Technology Vendor Collaboration with Mike Wenger
    Nov 14 2025

    To get more insights about clinical research technology from a vendor's perspective, I invited Mike Wenger on the Clinical Trial Podcast.

    Mike Wenger is a software developer with over 15 years of experience creating innovative solutions in clinical research.

    At the Michael J. Fox Foundation for Parkinson's Research, he worked to connect Parkinson's patients with clinical studies.

    He later developed Citeline Connect, bridging patient recruitment companies with pharmaceutical organizations, and founded VersaTrial to streamline clinical trial site workflows.

    Mike is currently the Chief Innovation Officer at CRIO, an intuitive eSource solution that collects data directly at the point of patient interaction to lighten site burden while driving protocol compliance.

    Please join me in welcoming Mike on the Clinical Trial Podcast.

    This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 37,000 study sites, sponsors, and CROs in 90 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com

    This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

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    1 hr and 29 mins
  • Inspection Readiness with Donna Dorozinsky
    51 mins