Background The US FDA has a long history of facilitating expanded access (EA) to promising new investigational drugs for patients suffering from serious or life-threatening conditions who have no viable alternative treatment options available to them. In [...]
Your Site Initiation Visits Done RightAs a Project Manager (PM) working closely with Clinical Research Associates (CRAs) to manage Site Initiation Visits (SIVs), I understand how pivotal these meetings are, as they set the tone for the entire [...]
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, [...]
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) [...]
