Early Access System Platform
Early Access Care is the solution to pharmaceutical company compliance with the new legislation as it pertains to Expanded Access.
The Early Access System™ is our proprietary web-based platform 'all in one' tool for managing Expanded Access and Compassionate Use requests.
Benefits for Pharmaceutical Companies
- The technologic innovation of the Early Access System™ creates value
- Relieves administrative burdens and shifts valuable resources to drug development
- Leverages the power of technology to connect pharmaceutical company stakeholders involved in the review and approval of Expanded Access and Compassionate Use requests
- Actions occur in tandem enhancing workflow
- Review and approve requests using the turn-key platform
- Real-time visibility into the progress of each request
- Requests from ClinicalTrials.gov, FDA Navigator, or your company's website can be directed to the Early Access System™
- Customizable solution for each pharmaceutical manufacturer
- Trusted and secure HIPAA compliant server
The Early Access System™ can be managed and administered by Early Access Care or self managed by the pharmaceutical manufacturer.
The Early Access System™ platform can be licensed by pharmaceutical manufacturers to manage expanded access requests.