Full Clinical Trial Consulting and Program Support
Our clinical, regulatory, and laboratory services are integrated, offering full clinical trial consulting and support, from strategy development through regulatory interaction and filings. Our clinical services are also provided on an “as needed” basis, filling in the gaps where you might lack resources or expertise.
Our clinical, regulatory, and laboratory services are integrated, offering full clinical trial consulting and support, from strategy development through regulatory interaction and filings. Our clinical services are also provided on an “as needed” basis, filling in the gaps where you might lack resources or expertise.
The following provides a key list of clinical trial consulting services:
Clinical Program Support
- Clinical and regulatory strategy
- Pre-IDE development
- Predicate determination
- Program design, implementation, oversight
- Regulatory filings and submissions, interactions
Clinical Trials Support
- Site selection, qualification, agreements, management
- IRB, ethics committee, both external and internal
- Sample procurement, collection, processing
- Site documentation, development, management
- Site monitoring and management, all phases and closeout
- IUO reagent distribution and accountability and return
- Equipment management and return
Data Management
- Biostatistics, SAP, reports
- Data management plans
- Data collection tools, data capture (EDC, worksheets, eCRF)
- Database development, validation, support
Clinical Laboratory Support
- Preclinical primary or secondary site analytical studies
- Primary or secondary site clinical trial testing and sample management
- Assay bridging studies
- PacificDx, our fully accredited and licensed CLIA and GxP testing laboratory is a subsidiary of ResearchDx. It offers state-of-the-art facilities and expertise to meet your immediate clinical and pre-clinical needs for high-quality clinical and biopharmaceutical testing services.