Transforming Struggling Expanded Access and Post-Trial Access Programs
Expanded Access (EAP) and Post-Trial Access (PTA) programs are inherently complex. Even the most carefully designed initiatives can face unforeseen challenges as they progress. In these moments, Sponsors need a trusted partner to take over, that can stabilize operations, restore momentum, and ensure patients continue to receive critical treatments without interruption.
At WEP Clinical, we specialize in guiding programs through these transitions. Our team brings together regulatory expertise, operational excellence, and a patient-first mindset to transform struggling programs into streamlined, compliant, and sustainable solutions.
If you are thinking about transitioning your expanded access or PTA program away from your current vendor, click here to check out an article written by WEP’s Head of Expanded Access Program Strategy outlining her key considerations to keep in mind.
Our Approach to Seamless Transitions
When Sponsors transition a program to WEP Clinical, our priority is to make the process as seamless as possible. Continuity is critical, for patients, for physicians, and for Sponsor teams. Our structured transition model emphasizes:
- Transparency – open, consistent communication at every stage
- Collaboration – close partnership with Sponsors, sites, and stakeholders
- Stability – processes that ensure minimal disruption and uninterrupted treatment
The examples in the table below highlight how WEP Clinical has provided rescue support across a variety of therapeutic areas and geographies. Each example demonstrates how we applied tailored solutions to resolve challenges, maintain continuity, and deliver renewed confidence for Sponsors, sites, and physicians.
FAQs Around Access Program Rescues
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. Click here to access an article outlining the main challenges we hear from Sponsors who have transitioned their program over to WEP.
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.
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.
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.
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.
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.
Let WEP Provide Support for your Expanded Access or Post-Trial Access Program
By focusing on solutions, not setbacks, WEP Clinical has built a reputation for rescuing programs and restoring Sponsor trust. Our expertise enables us to unlock value, strengthen compliance, and keep patients at the center of every decision.
📝 Click here to check out a WEP case study providing specific detail into exactly how we supported one of our Sponsors with their Expanded Access Program rescue.
If your access program could benefit from additional expertise, proactive problem-solving, and patient-centered execution, WEP Clinical is ready to help you move forward with confidence.
