Co-Development Expertise
Expert advice on Diagnostic and biomarker strategies through the drug development process and to post launch
Matching suitable diagnostics partners to meet the differing needs and resources of clients
Technical support for Dx assessment, monitoring or evaluations
Project management of companion diagnostics co-development programmes and diagnostic studies
Diagnostic development expertise and advice
Regulatory and Quality Advice
Regulatory expertise and gap analysis to ensure the biomarker information and diagnostic test design are acceptable for approval
Assistance and training in establishing Quality management systems
Diagnostic implementation for drug launch readiness and post launch success
Expert advice on diagnostics strategies in the launch readiness and post launch phase to maximise drug uptake
Assistance implementing diagnostic strategies
Field force training to support diagnostic implementation
Establishing and manging diagnostic studies
Access to network of clinical laboratories and other healthcare professionals