Agenda for Day 2 – Wednesday October 7, 2026Wednesday, 7 October 2026 - EST/EDT (Eastern Daylight, GMT-4)

For those new to IRT or still building their foundation in the RTSM space, this facilitated workshop offers a practical and approachable introduction to the fundamentals of clinical trial technology:

• Build a foundational understanding of IRT and RTSM systems, their core functions, and their role in clinical trial operations

• Get familiar with key terminology, processes, and concepts you'll encounter across the field

• Ask questions and connect with peers in a welcoming, open environment

As basket, umbrella, and platform trials become increasingly common, IRT systems are being pushed to their limits.

• Investigate how IRT systems are evolving to support adaptive, multi-arm, and multi-cohort platform trial designs

• Address the operational and logistical challenges of managing randomization and trial supply management across multiple sub-studies simultaneously

• Review real-world approaches to building IRT infrastructure that can flex as platform trials evolve

Selecting the right IRT vendor is just the first step. Under the updated ICH E6(R3) guidelines, sponsors are held to a higher standard of accountability for vendor performance, making robust oversight programs essential for both compliance and operational success.

• Define what effective vendor oversight looks like in practice to ensure vendors meet performance and regulatory expectations

• Establish governance frameworks for clinical outsourcing that can scale across organizations of all sizes and complexities

• Understand how ICH E6(R3) is raising the bar on sponsor accountability and reshaping oversight responsibilities

IRT systems sit at the center of clinical trial execution, yet the teams managing them sometimes struggle to align with their cross-functional partners, creating friction that impacts trial timelines, data integrity, operational efficiency, and causes stress within the team.

• Identify the root causes of misalignment between IRT teams and clinical operations, supply chain, data management, and regulatory functions

• Explore real-world friction points in protocol design, system integration, amendments, and day-to-day operations that prevent effective collaboration

• Discuss practical strategies for building stronger cross-functional relationships and establishing shared accountability across teams

• Identify the most common inspection gaps in IRT and how to address them proactively

• Clarify what regulators are looking for in audit trails, documentation and system validation

• Investigate how evolving guidance, including ICH E6(R3), is reshaping expectations for IRT programs

• Evaluate key triggers for IRT system migration and how to evaluate whether the timing is right

• Discuss the operational, data integrity, and regulatory challenges of migrating systems mid-programs or between studies

• Explore best practices for managing vendor transitions without compromise trial continuity or compliance

Discuss practical frameworks for evaluating IRT vendors.

• Establish how procurement can be a strategic partner in IRT vendor decisions rather than a downstream gatekeeper

• Identify the criteria that matter most when selecting a vendor for complex, long-term studies

• Examine how IRT system requirements differ across Phase I, II, and III trials

• Address the operational and regulatory considerations unique to each phase

• Review how organizations can build IRT programs that scale as their pipeline matures

• Examine the upstream drivers of protocol amendments, including ambiguity in study design, late-stage decisions, and misaligned stakeholder expectations

• Understand how amendment-driven scope creep impacts IRT build timelines, UAT cycles, vendor engagement, and overall study costs

• Explore how sponsors are strengthening governance and setting clearer expectations across internal teams and vendors to reduce rework and downstream disruption