More than 500 therapeutic assets in Phase 2 or 3 development in the US have one or more CDx partnerships in place. Making fully-informed decisions and executing programs efficiently are the keys to success.
Qerity works globally with clients in the CDx development and commercialization space. The largest part of our practice addresses the needs of drug developers. We also work with IVD manufacturers and specialty laboratories that co-develop CDx assets and services to address the technology needs of pharmaceutical companies with targeted therapies.
Qerity respects the need for client confidentiality in the CDx space. These programs are critical for success during development and launch of targeted therapeutic assets. As such, the strategies and partners are proprietary.
CDx PROGRAM DESIGN
Qerity designs CDx programs to suit the needs of the client's asset. Whether the client is a drug developer, IVD manufacturer or specialty laboratory, Qerity knows the regulatory requirements, clinical operational needs and commercial approaches necessary to design effective development and commercializaiton programs.
CDx PARTNERING
Qerity develops partnering relationships for CDx programs. For drug developers, Qerity helps clients navigate the partnering process for manufacturing, testing, deployment, registration and commercialization of CDx assets and resources to support clinical development and launch of targeted therapeutic assets.
CDx OPERATIONS
Qerity helps clients with operational needs to deploy CDx programs. Drug developers need global solutions during development and launch. Qerity can provide management and oversight of laboratory validation, specimen logistics, data warehousing, phase-gate transitions, regulatory compliance and pre-launch / launch activities.
