Breakthroughs, Delivered With Care.
Connecting patients around the world with investigational medicinal products
Early Access Care connects patients who have rare and/or serious medical conditions with investigational medicinal products, when all available treatment options have been exhausted.
We use the FDA or each respective country's expanded access or compassionate use regulatory pathways.
Our experts guide biopharma companies in understanding the latest FDA investigational drug legislation or local regulatory compassionate use pathways to develop and implement the right solution for each investigational medicinal product.
We work directly with physicians in understanding all of the requirements to obtain an investigational drug for each patient expediting the overall process.
We streamline the entire compassionate use request process from submission, review, approval to drug delivery and resupply so biopharma companies can maintain their efforts and resources on their clinical trials.
Experience You Can Trust
- Over 50 years in drug development and 25 years compassionate use experience
- Global expertise of local regulatory requirements for expanded access (US) and compassionate use (non-US)
- Design of Expanded Access programs and policies
- Customizable eTool for your company
- FDA Navigator-ready
- End-to-end management—online request interface from approval to delivery of investigational drug to physician
- Working with IRBs and bioethical experts
- Experience with the FDA and global health authorities
- Expanded Access for Individual Patients
- Expanded Access for Groups of Patients (EAP or Cohort Protocols)
- Early Access System™
- Post-Trial Access
Our industry-leading platform gives you a simpler way to implement an expanded access program and gain valuable insights and data, potentially bringing life-saving experimental drug treatments to market faster.
Providing SeRvice Across the Globe
Want to learn more about our Expanded Access Capabilities?