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/