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.
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 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.