Early & Managed Access Programs
Early Access Programs are set up to enable patient access to medicine before it has been fully approved. These programs provide an opportunity for patients with serious or life-threatening conditions who cannot take part in a clinical trial to access a potential therapy. Through these programs, AcedrA and its partners are able to provide life-saving treatments to patients as quickly as possible. By making use of Early Access Programs, we help to ensure that people who need the most help can receive it in a timely manner. These programs provide a vital source of hope for those suffering from serious or life-threatening conditions, allowing them to access therapies that may otherwise be unavailable.
AcedrA, the champion of EAP in the MENA region
We are the champion of EAP in the MENA region with various successful track records in many institutions. Early Access Programs allow us to collect real-world data (RWD) on the safety and efficacy of our drugs in a larger patient population, which can help our partners to continue developing new treatments. By setting up Early Access Programs, we are able to provide life-changing treatments while also helping to advance medical research.
The programs that we can manage and provide services are:
- Named Patient Programs (NPP): either approved (Post-Approval) or clinical assets (Pre-Approval) with the legal ability to be exported to the MENA region
- Compassionate Use Programs (CU): granting access under special conditions to
- Clinical Supply Programs (CS): we can provide end-to-end solutions for clinical supply including clinical packaging, clinical labeling, comparator sourcing services, etc.
Named Patient Programs
Pre-Approval NPP and Post-Approval NPP are effective ways for our partners to provide early access to treatments that may not be otherwise available. By taking part in such programs, we can ensure that our products are getting into the hands of those who need them most and gain valuable insight into how their treatments are being used. It is clear that we must continue to explore new ways of providing early access in order to keep up with the changing needs of patients and make sure that no one is left behind.
Compassionate Use Programs
Compassionate use programs are an important reminder that we have a responsibility to use our expertise and resources to make the world a better place. Compassionate use programs can be the difference between life and death for some, and we are in a unique position to help those in need. By providing access to treatments before they become widely available, our partners can make a huge difference in the lives of those who need it most.
Clinical Supply Programs
These programs involve the strategic coordination between the management of manufacturing, distribution, and storage, which needs to ensure an adequate supply of medications while maintaining cost-effectiveness. We can save time, money, and resources while providing the best possible care to our patients. This includes also taking care about the best alternative to source for a clinical trial or study, the adequate packaging and labeling.
Let one of our access champions contacts you
Your inquiry will be sent directly to our early access team, EAP@acedrarx.com