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.

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