Companion Diagnostics (CDX) Services
Our range of CDX services are comprehensive and cover nearly every phase of product life cycle.
- Technology Selection
- Six Sigma Process Excellence
- Assay Validation
- Statistical Analysis
- Reference Range/Decision Threshold Setting
- Process Improvement
- Presentation
- Report Writing
- Presentation at Scientific Forums
- Publications
- Managing complex studies
- Time-line to success
- Alignment between CDx and Rx Development
- Risk Assessment/Mitigation
- Due-Diligence
- Partner Selection
- Contract Negotiation
- Contact Oversight
- Audit
- Risk Determination
- Pre-Sub
- IDE
- Submission
- US/EU/Japan/China
- Protocol Review
- Co-Authorship
- Testing/Reporting
- CDx Operational Support
- Patient Selection/Management
- Data Management
- Launch planning
- Market Research
- Go To Market Readiness
- Pricing/Reimbersment
- Marketing Support
- ISO Certification
- Quality Systems
- Design Control
- Audit
- Compliance
- Precision Medicine
- Dx Strategy
- Complementary vs. Companion Dx
- IP and Publication
- Risk/Benefit Assessment