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. [...]
In today’s clinical development landscape, no two trials, or trial Sponsors, are exactly alike. Each organization brings its own needs, priorities, and operating models to the table. For this reason, outsourcing strategies for clinical trials can vary widely. Some Sponsors prefer to engage multiple specialized vendors, selecting only the services they need to complement their internal capabilities. Others opt for a single, full-service CRO to manage the entire trial, leaning on a unified partner for seamless execution.
Working on clinical trials in the home means I view firsthand the positive impact mobile nursing can have on patients and their families.When a patient is living with a rare disease, they not only have [...]
Expanded Access Programs (EAPs) allow patients with serious or life-threatening conditions to obtain investigational treatments outside of the clinical trial setting. Because they are not formal clinical trials, EAPs do not require as much data [...]
Expanded/Early Access (EA), Compassionate Use (CU) and Named Patient Use (NPU) are critical pathways for patients with serious or life-threatening conditions to obtain investigational treatments outside of clinical trials. While these programs offer hope for [...]
Earlier this month, WEP Clinical had the incredible opportunity to participate in the prestigious World Economic Forum (WEF) Davos event, as a proud sponsor of the Partner for Patient conference, HEAL - Health Equity Action [...]
Interested in collecting data during your access program, but haven’t decided on what you would like to use it for? Let WEP help provide some guidance. While there aren’t specific regulations that guide the collection [...]
Previously, I discussed common challenges faced by Sponsors dissatisfied with their access program vendor's service. You can read the full article by clicking here.If any of these issues resonate with you, know that you're not [...]
Feeling dissatisfied with the level of service provided by an Access Program vendor is not uncommon for pharmaceutical and biotech companies. Many Sponsors that choose to outsource the management of their access program(s), be it [...]
