Accelerating Vaccine Development Through Community-Based Pharmacy Clinical Infrastructure The partnership between WEP Clinical and RxE2 establishes a differentiated model for vaccine trial execution: one that leverages the accessibility of community pharmacies alongside global clinical [...]
A WEP Clinical White Paper With Every Patient In Recognition of International Childhood Cancer Day - February 15 Executive Summary Scientific innovation in pediatric oncology has accelerated, yet clinical trial participation among children with cancer [...]
A WEP Clinical White PaperWith Every PatientIn Recognition of World Cancer Day – February 4 Executive Summary Each year on World Cancer Day, the global oncology community reflects on both progress made and the work [...]
The FDA’s expectations around equitable access and representative enrollment in clinical research have moved from encouraged to operationally expected. With the FDA’s Enhancing Participation in Clinical Trials - Eligibility Criteria, Enrollment Practices, and Trial Designs final guidance (published December 15, [...]
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, [...]
