Archives: Agenda

Developing a Clinical Oversight Strategy Using Big Data and BI Tools

·        Enhancing oversight of CROs, vendors, and trial sites through centralized data insights

·        Utilizing Business Intelligence (BI) tools to visualize trial health in real time

·        Case examples of effective use of BI tools in optimizing clinical timelines, cost, and compliance

Exploring New Frontiers in Radiopharma: Global Strategies for Clinical Success

• Following recent shifts in the FDA landscape, radiophama developers are increasingly exploring alternative regions and pathways to advance early-stage programs more efficiently
• Global interest in radiopharma including Korea’s rapidly growing focus, reflects a strategic move toward more flexible, collaborative, and regionally diversified development models
• Novotech’s multi-country radiopharma studies demonstrate an agile and integrated approach, showing how a CRO can deliver end-to-end support from preclinical planning to late-phase execution

Building Resilient Clinical Supply Chains: From Seamless Comparator Sourcing, Labeling, Packaging to Last-Leg Delivery in Global Clinical Trials

This session, will provide an insightful overview of how Jupiter Research Services’ bespoke service model enables Sponsors, CROs, and CDMOs to leverage a truly global and resilient clinical supply chain – encompassing Seamless Comparator Sourcing, Regulatory-Compliant Labeling & Packaging, and Efficient Last-Leg Delivery across multi-regional clinical trials

  • Identifying, Mapping & Mitigating Risks in a Volatile Supply Chain
    – Understanding how global shortages, parallel trade shifts, customs complexities, and cold-chain vulnerabilities impact study timelines—and how to proactively mitigate them.
  • Resilient & “Glocal” Comparator Sourcing Strategies
    – Approaches that combine global reach with local execution to reduce bottlenecks, prevent study interruptions, and secure critical US/EU comparator products for global trials.
  • Overcoming Regulatory Challenges for Uninterrupted Study Operations
    – Navigating FDA, EMA, MHRA, MFDS, PMDA, CDSCO, DSCSA/EPCIS, and QP release requirements to maintain continuity and compliance across regions.
  • Integrated Labeling, Packaging & Blinding for OTD (On-Time Delivery)
    – A coordinated, risk-based approach to labeling, packaging, kitting, and blinding that ensures accuracy, compliance, version control, and timely delivery.
  • Application of JIT, DTP & Innovative Supply Models
    – Deploying Just-in-Time (JIT) packaging, Direct-to-Patient (DTP) distribution, and flexible logistics models that support decentralized and hybrid trials.
  • Case Studies: Successful End-to-End Execution
    – Real-world examples demonstrating rapid comparator procurement, seamless global-to-local execution, proactive QA oversight, and uninterrupted delivery to sites and patients.