Archives: Agenda

• Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
• Balancing cost, quality and timelines within tight budget constraints
• Negotiating contracts with flexibility to protect your biotech’s goals

This session will explore whether the FDA’s Real-Time Clinical Trials (RTCT) program is an aspirational vision for the future or a near-term reality that biotech companies should begin preparing for today. This session will discuss what sponsors can do now to position themselves for participation in this emerging real-time development model.

• Separate hype from reality: Examine FDA’s stated goals for RTCTs, the scope of the pilot program, and its potential opportunities and limitations.
• Understand the broad operational and technology requirements: Identify the critical capabilities needed for participation in the pilot program.
• Develop your biotech readiness roadmap: Discuss practical actions sponsors can take today to assess their organizational readiness and engage with FDA as the RTCT model evolves.

• What “real time” looked like from the sponsor side when site activity became visible only after the work was complete
• How late queries and accessioning delays slowed data readout in a Phase I oncology study
• What changed when issues were identified and corrected before shipment
• Why clinical trial execution is foundational to better data and AI-ready trials

Hybrid operating models offer flexibility in how sponsors and CROs divide responsibilities, but success depends on how effectively those responsibilities are integrated across the study lifecycle. Drawing on lessons learned from a complex oncology clinical trial with an accelerated start-up timeline and sites selected before CRO engagement, this session explores practical strategies for establishing clear governance, coordinating sponsor- and CRO-managed functions, and creating a unified operational approach that accelerated site activation, supported first patient in, and sustained enrollment momentum despite a highly distributed delivery model.

The session will explore:

• Defining clear sponsor and CRO roles, governance structures, shared timelines, ownership, and decision-making frameworks to drive accountability and enable seamless execution within a hybrid operating model.
• Managing cross-functional vendors, technology integrations, and operational dependencies to proactively identify and mitigate execution risks.
• Building a unified sponsor-CRO approach for site engagement through aligned communication, coordinated oversight, and shared expectations to strengthen collaboration and enhance the site experience.
• Applying cross-functional readiness planning and proactive risk management strategies to accelerate study start-up, support first patient in, and drive enrollment success.