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Treatment IND & Compassionate Use Programs
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Covance has over 19 years of experience with Expanded Access Programs (EAPs) in many therapeutic areas. EAPs allow innovative new therapies for life-threatening diseases to be given to expanded populations prior to FDA approval. Covance has developed a number of solutions to address concerns specific to EAPs:
- High patient enrollment demands
- Limited availability of investigational product
- Cost recovery and third-party reimbursement.
Expanded Access Programs
- Treatment Investigational New Drug (TxINDs) programs
- Compassionate Use programs (CU)
- Emergency use protocols.
Treatment IND & Compassionate Use Programs
- Provide access to important new drugs during development
- Collect safety data in broad populations (pre-marketing surveillance)
- Address particular areas of interest or concern.
High Patient Enrollment
Covance has developed specialized systems for prompt initiation and effective operation of TxIND and CU programs. These include computerized patient screening and optical scanning of Case Report Forms. Other specialty services include providing project specific information to physicians, patients and patient advocacy groups, data acquisition, analyses and reporting systems.
Limited Availability of Investigational Product
The demand for investigational product frequently exceeds the available supply in EAPs. Covance manages this situation through a number of approaches including:
- Managing drug shipment and availability with the Interactive Voice Response System (IVRS)
- Directing patients to a registered site
- Adding patients' physicians to a waiting list
- Enrolling patients into a lottery for drug distribution.
Clinical-to-Commercial™ Transition Programs
As studies for chronic therapies end, companies need to ensure that patients continue therapy. Covance pioneered the Clinical-to-Commercial™ transition program, which helps patients smoothly transition from free clinical product to insurance coverage for the commercial product. Transition programs improve patient compliance and speed market uptake.
Reimbursement Strategies
The FDA also allows for cost recovery during tINDs especially through third-party reimbursement. Covance provides reimbursement counseling to convert enrolled patients safely to a commercial product while understanding the important treatment needs of the patients. |
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