Maximize access. Manage risk. Plan for success.
Risk management is crucial to the value of your brand – and creating a Risk Evaluation and Mitigation Strategy (REMS) can be a challenging and complex process. Covance Market Access Services has the risk management expertise and REMS experience you need to succeed.
Whatever stage your product is in – from development to managing REMS requirements – we can help you design, implement, and manage a customized risk management program of any scope. Our history of REMS success is built on assured excellence, innovation, and on-time delivery.
What is a REMS?
The Food and Drug Administration Amendments Act of 2007 (FDAAA) included authorization to require the implementation of a REMS in order to ensure that the benefits of a drug outweigh its risks (positive benefit-risk balance). Evaluation of the need for a REMS should begin early in the drug development process and continue through approval and commercialization.
Covance offers a full spectrum of REMS services:
REMS/Regulatory Consulting
- Attendance at pre-NDA meetings
- Advisory Committee preparation (subject matter expertise consulting)
- Assessment of likelihood of REMS requirements
- Recommendations for REMS elements/design
- REMS consulting in combination with reimbursement and patient assistance support, call center services, and post-marketing requirements
REMS Submissions
- Preparation of proposed REMS, REMS supporting documents, and associated attachments
Medication Guides
- Development of Medication Guides
- Survey and protocol development, pre-testing, and operations
- Data analysis and FDA reporting
Communication Plans
- Materials design and development
Elements to Assure Safe Use (ETASU)
- Database design and development for multiple stakeholders
- Design and development of implementation systems
- Analysis of data from external surveillance data systems (e.g., National Poison Data System)
- Tracking of stakeholder training
- Data analysis and FDA reporting