Clinical Research
ResearchDx can design, manage, and coordinate all aspects of clinical trials for the development of a diagnostic product from assay concept through to regulatory submission and commercialization. Some examples of our clinical research services include:
- Development of novel assays or validation of established assays
- Clinical research project development, management and conduct
- CRF/Study document development
- IRB submissions and management
- Laboratory services
- Management of FDA submissions for 510k or PMA
- Writing papers for publication
Development of novel assays or validation of established assays
Our team of scientists and technicians are experienced in assay development and validation at all stages of the process from concept and discovery through to final validation. We can support your assay development needs from any point along the way.
Clinical research project development, management and conduct
From supporting the execution and monitoring of your clinical trial through to complete product development planning and program / protocol development, ResearchDx can provide you with the level of clinical development support your organization needs to effectively and efficiently develop your diagnostic.
CRF/Study document development
ResearchDx has a library of templates for the development of the necessary documents for capturing and documenting all aspects of a clinical trial. We can meet custom development needs and utilize established client documents.
IRB submissions and management
ResearchDx has an established relationship with an IRB that specializes in Diagnostics Clinical Research and can support all aspects of IRB submissions and supplier 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.
Management of FDA submissions for 510k or PMA
Our staff has experience interacting with regulatory agency personnel from pre-IDE through to final approval, including negotiating requirements, developing and defending 510k and PMA submissions.
Writing papers for publication
In addition to writing regulatory submissions, ResearchDx will develop and submit papers for publication in support of increasing awareness for your company, your diagnostic and its commercialization.