Your Clinical Research Experts for

Medical Devices

Your Site. Our Eyes.

We’ll focus on earning approval so you can bring your device to market faster.
OUR PROCESS

A Trusted Partner

In Compliance

IMARC is a leading clinical research organization that specializes in ensuring compliance at every stage of an investigational study, from clinical planning to study closeout. Learn more about how our process protects the integrity of your study and enhances your team’s efficiency. 

IMARC Process
Assess
Process
Advise
Process
Earn Approval
IMARC Training
Training with IMARC

Training It’s in Our DNA.

Did you know that IMARC offers training for Medical Device Research Professionals?
Elements of a Regulatory Inspection
FEATURED DOWNLOAD

ELEMENTS OF A REGULATORY INSPECTION

WHAT YOU NEED TO KNOW

While audits of studies with pending marketing applications are considered routine, FDA has recently shifted its focus toward an early intervention paradigm. Under this design, BIMO inspections occur prior to trial completion. This approach allows FDA the opportunity to affect proactive change and continuously improve clinical investigator compliance. Early intervention inspections can be more difficult to predict as the audits are not necessarily triggered by a sponsor regulatory submission.

IMARC Services

Our Services

IMARC offers a comprehensive package of services to complement your team at every stage of your clinical trial, from planning to closeout. Learn more about how we help your team achieve its goals.