What are Expanded Access and Post-Trial Access Programs?
Expanded access (EAP) and Post-Trial Access (PTA) programs allow eligible patients suffering from serious or life-threatening conditions to receive investigational therapies outside the traditional clinical trial setting. Expanded access focuses on providing investigational treatment to eligible patients that are unable to enroll in active clinical trials. PTA ensures continuity of care for prior participants, once a study comes to an end. Governance, consent, supply and reporting pathways overlap but are not identical.
Turning Expanded Access and Post-Trial Access Programs into Strategic Assets:
The immediate goal of any access program is clear: get eligible patients timely access to treatment. At WEP, we strongly believe that in addition to serving patients, EAPs and PTA programs can do so much more for a Sponsor. When access programs are thoughtfully designed and expertly run, they generate strategic value and provide important insight for Sponsors.
Your EAP and PTA Programs should be strategically built to:
- Strengthen relationships with investigators, KOLs, and patient communities
- Capture real-world evidence that informs ongoing or future clinical development and medical strategy
- Provide early signals that guide country prioritization, supply planning, and payer discussions
- Demonstrate responsible access and governance to regulators and external stakeholders
These insights and benefits are not a given. To achieve these, a Sponsor must find a strategic partner with expert strategy and operations teams that listen, adapt, and understand how to continuously improve and scale your program over time. Not all vendors truly offer this. We often tell our clients to avoid the false economy of ‘lowest cost’ (Further reading: Balancing cost and quality in EAP/PTA programs) as often times, low-cost vendors do little more than distribute drug to patients.
💡 Key takeaway for Sponsors: The magic really happens when experienced teams of people translate Sponsor intent into day-to-day action that keeps pace with the nuances that define each individual access program.
EAP and PTA Program Partner Selection Criteria:
1) Seamless hand-off from Sales to Operational teams
Collaborative hand-off from Sales to Operations, with ongoing alignment, means no detail gets lost in translation and allows project delivery teams to progress with full clarity and confidence. Your vendor should provide one unified team, one continuous conversation, and outcomes that match exactly what was promised. WEP Clinical purposefully builds consistency into workflows.
2) Dedicated, expert project management
Access programs are context heavy: eligibility requirements, unique regulations and access requisites, ethics expectations & demands, and local site culture will all vary by country and across the life of the access program. An expert PM team anticipates challenges, navigates complexities, and provides customized solutions, without creating unnecessary burden for sites or Sponsor teams.
3) Meaningful data, not just fields
Beyond tracking requests and shipments, your partner should interpret patterns (e.g., request patterns, safety signals, geography-specific bottlenecks) and convert them into practical recommendations for clinical and medical teams. Data-driven decision-making and expert oversight keep a program performing optimally over time.
4) Direct engagement with stakeholders
Regular human-to-human conversations with HCPs, KOLs, advocacy groups, and regulators uncover friction early. These conversations can accelerate approvals, improve site and patient experiences, and strengthen future readiness. The human element must remain at the forefront when executing an access program.
5) A governance model that balances speed and rigor
It is vital to set clear decision criteria and escalation paths with pragmatic documentation, to keep programs compliant and responsive. Risk-based oversight and pre-defined roles prevent decision paralysis.
6) Continuous improvement
How WEP Clinical Designs & Delivers EAPs and PTA Programs
Your access program should be a strategic asset: human-centered, adaptable, and insight rich. Choose a partner that will listen, tailor guidance to your context, and help you get the most value from your program over time.
At WEP, we pride ourselves on our people-first approach. Our strong operational teams and project management-first delivery model is best-in-class. Our people are hired and trained for judgement, communication, and stakeholder engagement. We prioritize clarity, speed, and continuous improvement, so Sponsors can deliver timely treatment for patients and capture insights that advance their asset and inform future clinical development and commercialization efforts.
EAP and PTA Program Resources
🔎 Click here to access our free expanded access resource outlining key considerations for companies planning an EAP.
📝 Click here to check out our PTA case study detailing how we supported a biotech company with a global PTA program.
