Clinical Research / Clinical Trial Support

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ResearchDx was founded on the core principles and expertise that help diagnostics companies optimize the pathway to the laboratory for their in vitro diagnostic products (IVD). We manage the entire IVD development process – from initial assay concept and discovery, through clinical research to regulatory clearance (or approval as necessary), to validated CLIA implementation.

ASSAY DISCOVERY SERVICES

ResearchDx specializes in customized biomarker discovery through an unparalleled compliment of services that includes non-clinical / pre-clinical sample access and processing capabilities, comprehensive genetic and genomic testing platforms, and bioinformatics expertise. Our expert development teams are highly skilled in an array of technologies including DNA sequencing (Sanger and Next-Gen technologies), gene expression (Microarray, fluid array technologies Digital and Quantitative PCR), genotyping (SNPs and gross chromosomal abnormalities), flow cytometry and ELISA. Whether your project includes testing one or ten thousand samples, we are equipped with multiple platforms to reliably meet different throughput requirements.

CLINICAL PROGRAM SUPPORT

  • Pre-IDE Development, Regulatory Strategy, and Predicate Determination
  • Clinical and Non-clinical Project Requirements
  • Program Design, Implementation and Oversight
  • FDA Interactions, Submission Assembly and Follow-up

CLINICAL PROJECT SUPPORT

  • Project Management
  • Project Monitoring (Initiation, Interim and Closeout)
  • Site Identification, Qualification and Management
  • IRB / Ethics Committee: Central and Local Submissions and Management
  • Sample Procurement, Collection, Processing, Distribution and Accountability
  • Study and Site Documentation Development and Management
  • IUO Reagent / Equipment Management, Distribution, Accountability and Return

DATA MANAGEMENT

  • Statistical Analysis Plans
  • Statistical Project Management and Support
  • Statistical Analysis, Reports and Tables
  • Data Management Plans
  • Data Project Management and Support
  • Data Collection Tools (Worksheets, CRF, eCRF)
  • Database Development, Validation and Management

LABORATORY SERVICES

  • Our laboratory facilities provide sample testing for subjects participating in the pharmaceutical trials related to a diagnostic as well as acting as a testing site for the development of the diagnostic itself. As a CAP / CLIA certified facility we can also provide patient sample testing following development.
  • Research Level Assay Evaluation and Optimization
  • CLIA Level Assay Validation and Technical Transfer
  • CLIA Level Testing (IVD Test Site, Pharmaceutical Reference Lab, Clinical)
  • Secure Online LIMS access to all Subject results.