Access Program Rescue: Ensuring Continuity, Compliance, and Patient Care

FAQs Around Access Program Rescues

1) Why should a Sponsor consider switching EAP or PTA program vendor? 

Feeling dissatisfied with the level of service provided by an access program vendor is not uncommon for pharmaceutical and biotech companies. Read Why Sponsors Choose to Switch Access Program Vendors for an overview of the main challenges we hear from Sponsors who have transitioned their program over to WEP.  

2) Can you switch your vendor mid-program? 

Yes, it is possible to switch vendors mid-program. For many Sponsors it may be necessary as their program evolves and their needs change, especially if there are is lack of forward-thinking; regulatory compliance issues; sites begin to lack consistent support and overall access to treatment; the Sponsor’s reputation is at risk; or the Sponsor’s time and resources are being pulled away from clinical trial efforts to help the current vendor manage the access program. 

3) How do you keep patients on drug during a vendor transition? 

The new vendor will work closely with the Sponsor and the incumbent vendor team to map every active site & patient and transfer applicable regulatory, PV, and logistics data. The new vendor will pre-position stock so there is no gap in quality release and supply chain integrity is maintained. The new vendor will provide daily reconciliations, a single point of contact for all queries, and scripted communications to sites, patients, and regulators. This process is critical to ensure that dosing, safety reporting, and reimbursements continue uninterrupted.  

4) What are the compliance risks in an EAP rescue? 

Lack of a strong communication plan that outlines responsibilities of all parties can lead to critical compliance risks, including: 

• Data/privacy: gaps in consent, GDPR/HIPAA, or REMS obligations.
• PV continuity: incomplete transfer of patient data or safety cases, missed SUSAR/CIOMS timelines.
• Operations: lapses in QMS (GCP/GDP/GMP), QP release, import/export licenses, or chain-of-custody/cold-chain records can all trigger non-compliance.  

This is why it is so important to partner with a vendor that has acute experience handling rescue transitions.  

5) How long does a typical program transition take?

Transition timelines will vary based off the complexity of the existing EAP. WEP’s approach is designed to move quickly while staying compliant and process driven. We focus first on stabilizing patient dosing and shipments, then progress to transitioning components of the EAP (site/ethics, pharmacovigilance, and data), and finalize full integration of the program into WEP’s control. For straightforward transitions, this process is often measured in weeks rather than months. More complex rescues may take longer and proceed in carefully sequenced phases. When urgent needs arise, we mobilize rapidly to protect continuity of care, assuming the necessary approvals and access are in place.  

6) What KPIs prove a successful rescue?

We look for clear evidence that patient care is uninterrupted, operations are stable, and compliance is fully maintained. Practically, this means: 

• Patient continuity: No interruptions to dosing. 
• Operational reliability:  Rapid stabilization of ordering and supply chain processes, consistent on-time shipments
• Data integrity: Complete, verifiable data and documentation transfer with preserved chain-of-custody. 
• Compliance & safety: Timely safety reporting with full case reconciliation, sites transitioned within the planned window, no transition-related protocol deviations, strong patient retention, and clean audit/inspection outcomes.