Centralize and Simplify the Management of Expanded Access Programs with our collaboration portal
Expanded and Managed Access Programs supports sponsors to reach out to patients who were previously ineligible for trials and show value which could not be seen before while increasing the value of the product portfolio overall. With demand for early access to life saving medicinal products increasing, many countries including United States, Europe, Japan, Canada, etc. have develop a regulatory framework for regulating access.
Having an Expanded Access Program earlier in medicinal product development can also benefit sponsors in multiple ways. However, these benefits are offset by the multiple challenges and obstacles a sponsor or a CRO faces during the lifecycle of program. These include and are not limited to defining program, approval tracking, informed decision making, data management, continuous oversight, financial expectations, program tracking, transition planning, regulatory compliance and adhering to standard operating procedures.
A powerful solution to manage all types of Expanded Access Programs in a regulatory compliant manner
• Define pre-requisites for registration and submission of requests
• Define workflows and configure forms required for different stages of a program with options to collect documentations related to approvals and amendments
• Verify authenticity of registered users based on various datapoints (NPI, Practitioner Medical License Number, etc.)
• Using the received patient information, sponsors can evaluate their eligibility criteria for EAP participation
• Track submissions and approvals from regulatory body and Regional Ethics Committee
• Define Work Instructions and Help Content to support requestors for submitting different types of EAP applications and for sponsor’s internal users to evaluate requests
• Manage all email communication between external user and sponsor from application which is available within EAP request for future reference
• Perform expenditure tracking and trial related reimbursements
• Perform return and retrieval of investigational product
• Compile and analyze the collected Real-World Data (RWD) which can supplement clinical trial data when seeking marketing approval