Expanded Access Programs
Expanded Access Programs
Programs that provide patients access to investigational drug where there is an unmet medical need include: Expanded Access, Compassionate Use, and Named Patient. These are programs that help to provide "Right to Try" access. UBC is able to customize and support the best access approach for each unique therapy, ranging from individual treatment protocols to large patient populations.
Offer patients with life-threatening conditions availability to drugs through UBC’s Expanded Access Programs. Our experts can design, implement and manage global expanded access programs that provide needed medications, while preserving clinical trial patient populations and extending the investigational product to patients outside of clinical trials while commercial approval is pending. UBC’s commercial services make us uniquely positioned to bridge the gap between investigational product and commercial drug.
Enacting an Expanded Access Program is a balancing act. Patient needs, clinical trial progress, regulatory requirements, advocacy group concerns and availability of investigational drug are all important factors. UBC can support all healthcare providers, regardless of their level of experience in using investigational drugs or performing associated diagnostic tests required for treatment. UBC can address these needs while designing a program that can collect vital safety data from a patient population outside of the clinical trial setting. Our experts can provide:
- Consulting on protocol development
- Regulatory document preparation
- Site qualification
- Rapid and targeted start-up activities
- Initial and ongoing training
- Customized patient and site/clinical practice support tools
- Access to and training on a dynamic electronic data capture (EDC) system
Once a drug receives regulatory approval for marketing, patients in an EAP need to be transitioned into the commercial drug supply chain for ongoing care. It can take weeks — or months — to successfully move all patients to commercial product. UBC understands that an expanded access program must begin with a transition plan in mind.
Not only does UBC have the clinical team with expertise in writing EAP protocols and managing these programs, we also have reimbursement experts, Hub services, and nursing and adherence programs that allow for a streamlined transition from investigational product to commercial drug. Our team will ensure 1:1 coordination of patient to product, ensuring there is no gap in patient care and easing the process for investigative and physician staffs.
Commitment to Success
UBC has managed expanded access programs for numerous disease states, including HIV, oncology, multiple myeloma, cystic fibrosis, Alzheimer’s disease, and other rare diseases.
Contact us to leverage our expertise for your EAP.