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 [...]
What do the FDA Mean by Real-World Data?As the clinical research landscape progresses, so do the expectations of regulators. The U.S. Food and Drug Administration (FDA) has made it clear: real-world data (RWD) has the [...]
Access to unlicensed or investigational medicines outside of clinical trials prior to marketing authorization plays a critical role in addressing urgent, unmet clinical needs in patient populations. Within the European Union (EU), such access is [...]
At first glance, choosing a low-cost vendor to manage your access program may seem like the most practical business decision. However, some Sponsors quickly find that the “low-cost” option results in higher long-term expenses, lack [...]
In the ever-evolving and increasingly complex clinical landscape, mobile nursing services have become a cornerstone of clinical research efforts. But not all mobile nursing models are created equal. At WEP, we made the strategic decision [...]
In the evolving world of clinical research, one reality remains unchanged: running a successful clinical trial is hard. Recruitment lags, retention falters, sites are stretched thin, and access remains unequal. At the heart of these [...]
In clinical research, the relationship between the Site and the CRO - more specifically, the Site and the CRA - is the foundation of any smooth running project. As a former Clinical Research Coordinator (CRC) [...]
Early Access Programs (EAPs) in France provide pharmaceutical and biotech companies with a valuable opportunity to offer patients innovative treatments before obtaining formal marketing authorization. Regulated by the French National Agency for the Safety of [...]
In my previous article, "One Size Doesn’t Fit All: Why CRO Flexibility Matters More Than Ever" I discuss how each clinical trial and each Sponsor has unique needs, meaning there can be no one-size-fits all [...]
The 5th Annual Operationalize Expanded Access Programs (EAP) Conference, held in Boston this March, once again brought together industry leaders and key stakeholders to discuss the evolving landscape of expanded access and post-trial access programs. [...]
