From January 2025, all clinical trials in the EU must comply with the Clinical Trial Regulation (CTR) and be submitted via the Clinical Trials Information System (CTIS) — a unified platform aimed at increasing efficiency, transparency, and harmonization across member states.
While this change is designed to streamline regulatory processes and accelerate approvals, it also brings new logistical and operational challenges for sponsors, CROs, and supply partners.
At PAM Pharm, we’re closely monitoring how these changes will impact:
Supply chain timelines – faster approvals mean shorter lead times and greater demand for agile logistics
Labeling complexity – multilingual, harmonized labels with frequent updates require tighter coordination
Forecasting and inventory – just-in-time manufacturing and direct-to-site delivery are becoming more critical
Digital readiness – transparency and compliance now depend on advanced digital supply chain systems
The shift toward centralized applications and increased traceability opens the door to greater efficiency — but only for those prepared to adapt.
As a partner in clinical trial supply, PAM Pharm supports sponsors and CROs in navigating this new regulatory landscape with tailored, flexible supply solutions across Europe.
