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Drug Agency Mandated Programs
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Covance has in-depth experience in planning, administering and providing analysis for large-scale programs that have been mandated by regulatory agencies to assess safety in medications. Our expertise in scientific research, managerial issues and procedures, and technology enable us to conduct each study to the most rigorous specifications.
Since all medicines have side effects, the endorsement to market a product hinges on the treatment value outweighing the known potential side effects. Regulatory agencies are responsible for approving important new therapies while ensuring the safety of the public. Agencies may require additional clinical trials to evaluate specific safety concerns for marketing approval.
Covance has developed specialized skills and systems to manage the challenges that agency mandated programs my present. We offer:
- Prompt study initiation
- Effective operation and project management
- Ongoing evaluation of safety parameters
- Computerized patient screening system
- Optical scanning of CRFs
- Standardized information exchange with Data Safety Monitoring Boards (DSMBs).
Data Safety Monitoring Boards (DSMBs)
Covance staff members serve as administrative assistants to the DSMB, in an ex officio capacity. Information exchange with the DSMB can be customized based on the sponsor's specific needs.
Endpoint Classification Committees (ECCs)
In large multi-site trials, consistent application of criteria defining clinical endpoints is necessary for success. An ECC is responsible for this critical function. Furthermore, Covance has learned that it is crucial to establish workflow procedures and standards in order to deliver a high quality and consistent endpoint package to the ECC.
Covance has experience in managing the logistics of an ECC, including:
- Tracking and reporting of data
- Endpoint review package assembly
- Input to the ECC charter and procedures
- Receipt and entry of classification data.
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