Clinical Trial Podcast | Conversations with Clinical Research Experts

Bringing a high-risk cardiovascular device from concept to patient care requires more than innovation - it requires carefully designed clinical trials, strong operational execution, and close collaboration with regulators and physician investigators.
In this episode of the Clinical Trial Podcast, Kunal Sampat speaks with Nicole Haratani about how cardiovascular device clinical trials are actually designed and run. Nicole is Vice President of Clinical Affairs at Supira Medical and has spent more than two decades working in medical device clinical research, particularly in cardiovascular technologies.
Nicole shares insights from her experience leading clinical and regulatory programs across feasibility and pivotal trials, and explains the operational realities behind Class III device studies.
In this episode, we discuss:
How cardiovascular devices move from concept to clinical trials
Designing feasibility and pivotal trials for Class III devices
How inclusion and exclusion criteria are developed
Challenges in patient recruitment for cardiovascular studies
Collaborating with key opinion leaders and investigators
Working with the FDA during the PMA process
Career advice for professionals interested in medical device clinical research
If you're interested in cardiovascular device development, clinical trial operations, or building a career in medical device research, this episode provides a practical look at how complex device trials are executed.

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:
Kristen McKenna, Senior Manager and Investigator Contracts Lead at Pfizer
Heidi Castle, Director of Business Development at Mercy Research
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.

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.

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

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/