Clinical Research

Full Clinical Program Support

At ResearchDx, our clinical, regulatory and laboratory services are integrated, offering full clinical program and trial 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 services; however, since we are able to provide full program support, if you don’t see what you need, just ask.

  • Clinical and regulatory strategy
  • Pre-IDE development
  • Predicate determination
  • Program design, implementation, oversight
  • Regulatory filings and submissions, interactions

  • 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

  • Biostatistics, SAP, reports
  • Data management plans
  • Data collection tools, data capture (EDC, worksheets, eCRF)
  • Database development, validation, support

  • Preclinical primary or secondary site analytical studies
  • Primary or secondary site clinical trial testing and sample management
  • Assay bridging studies