Regulatory expectations now extend far beyond manufacturing, making the logistics chain a major source of risk in today’s clinical research. Many still underestimate how GMP, GDP, and GxP requirements apply to storage, distribution, and cold-chain management, creating costly blind spots. Temperature excursions, labeling errors, and documentation gaps remain top causes of deviations and audit findings, directly threatening study integrity and patient safety.
These critical points will be explained by:
Steven Chavez, Senior Vice President and Head of Global Sales at OCASA Life Sciences, a leader with over 20 years of expertise in pharmaceutical logistics, cold chain solutions, and GDP/GMP-compliant global operations.
Laura Navarro, Senior Operations Manager for EMEA, specializing in temperature-controlled transport, regulatory compliance, and time-critical clinical logistics across Europe and international markets.
Building on this foundation, as trials become more global and decentralized, the lack of real-time visibility and validated cold-chain controls increases the chances of missed dosing windows and product integrity failures. In this context, choosing the wrong logistics partner can quietly introduce risks that only become evident during audits or incidents—when it’s already too late.
Register to discover how GMP-aligned logistics protect your trials
Learning objectives:
- Regulated continuum the importance of GMP principles extended into logistics
- The operations accounted to maintain product integrity through the supply chain
- Real world logistics risks and finding suitable reliable partners to mitigate them