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 [...]
In today’s fast-paced pharmaceutical landscape, selecting the right partner for your clinical trials is crucial. Here are some compelling benefits of opting for a small CRO: Personalized Attention Small CROs often provide tailored solutions and [...]
In the world of pharmaceutical development, Expanded Access Programs (EAPs) and Post-Trial Access (PTA) initiatives play a crucial role in delivering life-saving therapies to patients in need. These programs are essential for providing access to [...]
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 [...]
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 [...]
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 [...]
