A WEP Clinical White Paper With Every Patient Executive Summary Clinical trials have evolved significantly over the past several decades, driven by scientific innovation, regulatory modernization, and the increasing complexity of investigational therapies. Yet, despite [...]
Over the past few months, both the United States FDA and Health Canada have updated their guidance on expanded / early access. Although these changes haven’t radically rewritten the rulebook, they have raised the bar [...]
At WEP Clinical, we offer comprehensive Mobile Nursing solutions for Sponsors, CROs, and clinical trial sites around the globe. Our mission is to ease the burdens placed on all study stakeholders by allowing patients to participate in [...]
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 [...]
