Stratification in Clinical Trials
ResearchDx offers comprehensive support for running biomarker driven prospective trials and guidance for patient stratification in clinical trials.
Our goal is to deliver a cost effective, risk mitigated solution for design, development and validation of an assay to support your upcoming trial. We help with biomarker selection and validation, prospective patient enrollment, coordinating sample logistics, and clear strategic guidance for regulatory approval. We have a team of experts who understand the importance of identifying the right patients for your trial and have plenty of experience across the spectrum of technologies and platforms.
Whether you need proof of concept, initial assay design, tech transfer and validation or help with commercialization, we can deliver.
Biomarker Discovery / Validation
- Exploratory/Proof of Concept Studies
- RUO Assay Design and Development
- Assay Optimization
- Predictive Utility
- Bioinformatics/Biostatistics Support
Clinical Trial Support
- IUO/CTA Validation
- Sample Logistics
- Central Lab Testing
- Kitting and Distributed Deployment
- Fast Turnaround Time to Support Prospective Patient Enrollment
Regulatory/Manufacturing Support
- Regulatory Strategy
- IVD, PRE-IDE, PMA, 510(k) filings and FDA interactions
- International Regulatory Filings
- Compliance Auditing and Consulting
- ISO 13485 Manufacturing
- Custom Reagents, Assays, or Final Kits for Research, Clinical, or Final Product
- OEM Reagents, Kit Components or Assays
Schedule a consultation with our research team to discuss your specific needs.
