Post-Trial Access (PTA)

What Is Post-Trial Access?

PTA refers to the continued provision of a study drug to former participants who:

Have demonstrated clinical benefit during the study
Are not yet able to access the drug commercially
Need time to transition into another therapy

PTA is not a trial extension or a formal access programme — it is a bridge to protect patient wellbeing during regulatory or commercial delays.

How it works

Post-Trial Access (PTA) ensures that participants who benefited from an investigational product during a study can continue receiving it once the trial has officially closed.

Problem:

Clinical trials may end — but for many patients, the need for treatment continues.

Solution

At COREX, we help sponsors meet ethical obligations and local regulatory requirements by managing secure, compliant PTA supply chains across Europe, the UK, and CIS countries.

How COREX Supports PTA Implementation

Product Storage & Controlled Distribution

Documentation, Patient Matching & Compliance Oversight

Batch Tracking & Expiry Monitoring

Customs Clearance & Regulatory Coordination

End-to-End Project Management for Each Country or Site

Contact Our Team

Why PTA Matters

International guidelines (e.g., Declaration of Helsinki, EMA, WHO)
highlight the ethical obligation to continue treatment if stopping
it could harm the patient.

PTA is also a way for sponsors to: