Clinical laboratory · Clinical trials · Regulatory · Diligence
Expert guidance for clinical laboratories, IVD and medical device developers, and the investors who back them — from a team that runs its own CLIA-certified, CAP-accredited laboratory.
How our practices fit together
Join at any stage. Each practice stands on its own, and together they cover a diagnostic’s path from the first test run to investment and launch.
Build & run the lab
CLIA certification, state licensure, accreditation, and test validation.
Prove it clinically
Study design, IDE and IRB, site management, data, and trial testing.
Get to market
FDA pathway strategy, submissions, and QMSR and ISO 13485 quality systems.
Invest & commercialize
Technical due diligence, commercialization roadmaps, and reimbursement strategy.
Our consulting services
Choose the practice that matches your goal. Many clients use more than one as a program moves from the lab to the market.
Start, expand, and maintain a compliant clinical laboratory — from CLIA certification and state licensure to accreditation and inspection readiness.
Full clinical trial consulting and program support — from strategy and study design through site management, data, testing, and filings.
Regulatory, quality, and clinical affairs support for IVD and medical device companies — from pathway strategy to FDA submission and beyond.
Independent scientific, regulatory, and commercial assessments of diagnostic assays, technology portfolios, and companies.
Not sure where to start?
If you are
Why ResearchDx
Our consultants are scientists, laboratory directors, biostatisticians, medical writers, and regulatory specialists who apply the same standards in our own laboratory every day.
We will point you to the right team and the fastest path forward.