In recent weeks, many logistics experts have been closely monitoring the escalating situation in the Middle East. My feed has been filled with news of flight cancellations to Israel—last week alone, AIR EUROPA, AIR France, [...]
Imagine you're a patient You're a patient with an ultra-rare diagnosis, and there is a cutting-edge clinical trial available, but the nearest clinical trial treatment center is 5 states away. You and your family pack [...]
Expanded Access Programs (EAPs) are used to provide controlled and compliant access to investigational drugs for patients outside of the clinical trial setting. Many Sponsors choose to offer EAPs altruistically, as a critical treatment pathway [...]
Selecting the right CRO is crucial for biotech companies, as it can significantly impact the success of clinical trials and, ultimately, the development of new therapies. There are key reasons why value-added services are important [...]
Navigating the regulatory landscape for rare disease treatments can be challenging. One critical decision is determining the right time to seek an FDA special designation, such as Orphan Drug, Fast Track, Breakthrough Therapy, or Rare [...]
