IVD & device clinical studies · GCP · IDE
Full clinical trial consulting and program support for IVD and medical device companies — from strategy and study design through site management, data, laboratory testing, and regulatory filings.
Integrated clinical, regulatory & laboratory services
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. Either way, the study is designed with the regulatory submission in mind from day one.
Clinical study roadmap
The clinical evidence for an IVD or device submission is built in stages. We can lead every stage or support the ones you need.
Define intended use, predicate, endpoints, and sample size, and confirm the approach with FDA through a Pre-Submission.
Determine the study’s risk category, then secure IRB approval and, for significant-risk studies, an approved IDE.
Select and qualify sites, negotiate agreements, and prepare site documentation and investigational supplies.
Enroll subjects, collect and process samples, and monitor sites through every phase to closeout.
Test samples in a CLIA-certified laboratory, then manage and analyze the data under a prespecified statistical analysis plan.
Write the clinical study report and incorporate the results into your 510(k), De Novo, or PMA.
FDA’s Investigational Device Exemption (IDE) rules in 21 CFR Part 812 sort device studies into three categories. Getting the category right early sets your timeline and your approvals.
Typical for
Many IVD studies: noninvasive testing, no significant-risk sampling, and results confirmed by an established method
Approvals
No IDE, but IRB review and informed consent may still apply
Typical for
Studies that are not exempt but do not pose a potential for serious risk
Approvals
IRB approval with abbreviated IDE requirements; no FDA submission
Typical for
Studies with a potential for serious risk to subjects, such as results used for treatment without confirmation
Approvals
Full IDE application to FDA plus IRB approval before the study starts
Source: FDA, IDE Approval Process (21 CFR 812.2 and 812.20). Risk determinations are study-specific; we help you document yours.
Clinical trial consulting services
Ways to engage
We plan, run, test, and analyze your study as one integrated team, from strategy through the clinical study report and regulatory filing.
Add the expertise you are missing — a statistical analysis plan, site monitoring, data management, or sample testing — alongside your own team or CRO.
PacificDx can serve as the primary or secondary testing site for your clinical or preclinical study.
Tell us about your device, your intended use, and where your clinical program stands today.