Post-Trial Access
Post-trial access (PTA) allows Sponsors to provide access to their investigational drugs for patients after the clinical trial has ended.
What options exist at the end of your trial for continued drug supply to patients?
In some countries, such as Brazil and Israel, there are defined, mandated regulatory requirements around post-trial access commitments.
In other countries, such as the US, providing post-trial access is a choice. Sponsors have a number of pathways they can consider.
PTA programs help maintain treatment continuity for eligible patients while regulatory approval, reimbursement, or commercial availability is still pending.
What options exist at the end of your trial for providing continued drug supply to patients?
- In some countries, such as Brazil and Israel, there are defined, mandated regulatory requirements around post-trial access commitments.
- In other countries, such as the US, providing post-trial access is a choice. Sponsors have a number of pathways they can consider.
What options exist at the end of your trial for continued drug supply to patients?
In some countries, such as Brazil and Israel, there are defined, mandated regulatory requirements around post-trial access commitments.
In other countries, such as the US, providing post-trial access is a choice. Sponsors have a number of pathways they can consider.
WEP - Experts in Managing Post-Trial Access
WEP works closely with Sponsors to understand their unique clinical pipeline, trial activities, and overall goals for development and commercialization. We then advise on the best possible program, or combination of programs. We create bespoke solutions that may include any of the following:
- Post-Trial Access Programs
- Expanded Access Programs
- Roll-Over Studies
- Open-Label Extensions
- Long-Term Observational Studies
- Post-Approval Studies
WEP - Experts in Managing Post-Trial Access
WEP works closely with Sponsors to understand their unique clinical pipeline, trial activities, and overall goals for development and commercialization. We then advise on the best possible program, or combination of programs. We create bespoke solutions that may include any of the following:
Post-Trial Access Programs
Expanded Access Programs
Roll-Over Studies
Open-Label Extensions
Long-Term Observational Studies
Post-Approval Studies
What Program to Use
Our team will help you evaluate your options and determine the ideal solution. Factors that influence what post-trial access program, or programs, you should use include:
- Regulatory Requirements
- Patient Population
- Drug Supply
- Ethical Considerations
- Program Scope
- KOL Relationships
- Budget
- Data Collection
- Commercial Strategy
What Program to Use
Our team will help you evaluate your options and determine the ideal solution for continued patient access after a clinical trial ends. In some cases, Sponsors can utilize a single access pathway. In other cases, a combination of programs should be used to support patients responsibly while maintaining regulatory compliance and operational control.
Factors that influence what post-trial access program, or programs, you should use include:
- Regulatory Requirements
- Patient Population
- Drug Supply
- Ethical Considerations
- Program Scope
- KOL Relationships
- Budget
- Data Collection
- Commercial Strategy
Post-Trial Access Articles
Post-Trail Access Case Studies
Get in Touch
If you are a Sponsor and you would like to discuss your options for providing post-trial access, please complete the form to the left or contact us at:
We typically respond in under 24 hours.
Acting as a strategic Access Program partner – Going beyond the standard vendor approach
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