ClinCare Expanded Access

Expanded access programs steadily grow as chronically and terminally ill patients are granted access to investigational medicines before they come to market. By means of compassionate use regulatory exceptions, governments enable pharmaceutical companies to provide investigational medicines to those with demonstrated need who did not qualify for participation in clinical trials. These programs require the support of a secure and fully-integrated electronic data management system. ClinCare offers a proven approach to these expanded access programs, which are providing patients fitting within government regulations and meeting pharmaceutical company criteria with investigational drugs and devices.

ClinCare Expanded Access can be your strategic partner in successful expanded access program implementation (Medical Needs, Compassionate Use, Treatment IND, Emergency Use Protocol, or Named Patient Basis).

ClinCare Expanded Access features:

• Patient management
• Request and approve
• Enrollment monitoring & trend analysis
• Site-by-site metrics
• Inventory management
• Flexible management of timeline shifts
• Safety — reporting of Adverse Drug Reactions (ADRs)