Archives: Agenda

• How to transition from isolated clinical forecasting to unified, cross-functional demand planning that includes operations, quality, and CMOs from early on
• Protocol best practices: What helps clinical supply succeed, what gets written into a protocol that limits our options or creates complexity later on?
• The importance of integrating manufacturing lead times, capacity limits, and supply chain volatility directly into early-stage protocol design to build operational resilience
• How proactive communication allows the entire cross-functional chain to dynamically adjust to enrollment fluctuations without compromising compliance, timelines, or budget

Moderator: Irena Maksimovic

• How 3PLs and carriers can share data instantly to keep shipments moving smoothly from the warehouse shelf all the way to the patient’s bedside
• How to use smart, real-time tracking tools to spot temperature issues early and intervene before the medicine is ruined
• Avoiding Last-Mile Mistakes: Simple strategies to prepare clinical sites for high-stakes deliveries, ensuring onsite staff don’t leave fragile medicines sitting on a warm loading dock

Vendor Opportunity

• Move beyond superficial human error classifications by implementing robust RCA methodologies that identify the true systemic vulnerabilities in your clinical operations
• CAPA design matrix: Designing corrective actions that fix the underlying issue and preventive actions that protect other trials
• Tracking and analyze repeat deviations across multiple clinical protocols to catch systemic failures before an inspector does

• How to re-engineer the supply chain for Direct-to-Patient (DtP) delivery models, ensuring “last-mile” cold chain integrity and regulatory compliance in a home setting
• How to leverage eConsent and Remote Monitoring data to trigger automatic resupply shipments, reducing the burden on both patients and site staff
• How to adapt supply strategies for “Continuous Trials” and adaptive designs where patient cohorts and dosages change dynamically based on incoming data

Reserved vendor

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• Learn how to bypass manufacturer limits and get the exact commercial products your trials need
• How to implement data-driven forecasting to mitigate skyrocketing costs and minimize waste when procuring high-cost biologics
• Mastering regulatory traceability to navigate strict global compliance mandates to maintain uninterrupted, audit-ready clinical supply chains

• Designing for Modern Trial Complexity: Handling adaptive designs and mid-study protocol amendments seamlessly
• Mastering the Integration Ecosystem: Connecting IRT with other internal softwares to eliminate data silos
• Risk-Mitigation & Site Empowerment: Minimizing user error at the clinical site while automating inventory alerts

Vendor Opportunity