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Clinical Trial Supply & Logistics
- Clinical Trial Logistics
- Clinical Trial Supply
- Courier Services & Preconditioned Temperature Controlled Packaging
- GxP-Compliant Cold Chain Transport & Storage
- Decentralised Clinical Trials & Direct-to-Patient Logistics
- Labelling of Medicinal Products
- Laboratory Kits Preparation
- Protocol Review & Project Management
Medicines Access & Patient-Oriented Services
Regulatory & Importation Services
Expanded Access Programme (EAP)
Bridging the Gap Between Trial and Commercial Availability
What Is an Expanded Access Programme?
Early Access Programmes (sometimes called “pre-approval access”) provide proactive access to unlicensed medicines that:
- Have completed Phase III clinical trials
- Are undergoing regulatory review or awaiting launch
- Target serious, life-limiting, or rare conditions
- Are not yet available commercially in a given country
Unlike NPPs, EAPs are manufacturer-led, not requested by individual doctors, and typically follow an approved national framework.
How it works
At COREX, we partner with pharma companies and regulatory stakeholders to implement efficient, compliant EAP logistics across Europe, the UK, and CIS countries.
Problem:
An Early Access Programme (EAP) allows patients to receive a medicine before it’s commercially available, often while regulatory approval is still pending. Unlike Named Patient access, EAPs are usually designed for larger groups of patients, often at the request of the manufacturer.
Solution
Expanded Access Programmes allow patients to receive medicines before regulatory approval, often for larger patient groups at manufacturer's request.
How COREX Supports Expanded Access Programme
We act as the operational partner supporting the full EAP lifecycle:
Regulatory Strategy & Country-Specific Compliance
Importation & Storage of Unlicensed Products
Distribution to Hospitals or Clinical Sites
Customs Clearance & Documentation
Tracking and Batch Management
When to Consider an EAP
To maintain momentum after clinical trials but before full marketing approval
To serve patients in markets where launch will be delayed
To provide access in areas with no authorised treatment alternatives
To build real-world data and clinician awareness ahead of commercial entry
COREX Global Network
Ensuring seamless clinical supply solutions with local expertise and global reach.
Why choose COREX
for Expanded Access Programme?
Proven experience across multiple access programmes and therapeutic areas
Pan-European & CIS reach, with local compliance expertise
GxP storage, cold chain delivery, and customs-ready import pathways
Trusted by global manufacturers to execute ethically and efficiently
Seamless integration with your internal access or launch teams
