Clinical Research Services
Our clinical research team develops and executes comprehensive evidence plans that are fully integrated with your diagnostic design and development project, or on IVD products developed outside of DCN Dx.
- Complete, comprehensive clinical validation processes
- Clinical and regulatory strategy
- Specimen procurement for all stages of the product lifecycle
- Support of regulatory submissions
- Clinical data management and biostatistics services
- Data management
- IRB/ethics committee management
- Site identification, oversight, and management
- Integrated R&D department
- Supply and investigational product management
Total Clinical Study Management
Point-of-use diagnostic device research programs are complex. DCN Dx’s clinical research organization manages them from concept to regulatory submission to deliver the data you need to get to market the right way. We comply with local and Good Clinical Practice (GCP) guidelines, Good Laboratory Practice (GLP) principles, federal regulations, and more.
Clinical and Regulatory Strategy
DCN Dx considers every factor to develop regulatory pathways that make sense for your device. We’ll develop a formal roadmap you can trust to validate your point-of-use device early in the R&D process and save you time and expense.
Specimen Procurement
Leave the challenge of specimen procurement to DCN Dx. We work with a network of service providers to procure specimens to test with your diagnostic device.
Our Workflow
Our CRO team works closely with your DCN Dx Project Manager to determine the optimal research pathway for your diagnostic product.
An example clinical research workflow appears below.
- Protocol/ICF
- Statistical analysis plan
- Site identification & qualification
- Site contracting
- IRB/EC submission
- Regulatory document development
- Database development
- Trial master file (TMF) creation
- Acquisition of study supplies
- FDA pre-submission (if applicable)
- Site initiation visits
- Study monitoring
- Active site management
- Study supply management
- Safety reporting (if necessary)
- Data management activities
- Interim data analysis (as needed)
- TMF maintenance
- Database lock
- Site close-out visits
- Statistical analysis report
- Clinical study report
- Close IRB/EC
- Reconciliation of study materials
- Support of regulatory filing (as needed)
- TMF closure
Contact Us
PortaCheck (A DCN Dx Brand)
1388 Antelope Road
White City, OR 97503
1 (800) 964-6466
info@portacheck.com
Biomed Diagnostics (A DCN Dx Brand)
1388 Antelope Road
White City, OR 97503
1 (800) 964-6466
sales@biomeddiagnostics.com
