At Just in Time GCP, our team is knowledgeable of and has vast experience in clinical research operations, global health authority inspection requirements, eclinical systems, and trial management to assist your organization in achieving regulatory compliance and operational excellence and mitigate inspection risks.  We are experts in Good Clinical Practice (GCP) compliance, inspection preparedness, TMF management, technology implementation and optimization, and the processes that support clinical trial management and oversight including Trial Master File (TMF) management and support services.  We work with organizations to implement quality management systems (QMS) and processes that ensure standardization and mitigate inspection risk.  Our core products include Business & Technology Consulting related to the systems and processes that support an eclinical environment; inspection preparation and readiness activities related to strategy, inspection process, and TMF completeness/remediation; and the services that support the day to day management of the TMF.  At Just in Time GCP, we turn operational challenges into operational excellence.  Let us take the stress out of GCP compliance.

Clinical Trials

Life Sciences

Medical Devices

Just in Time GCP

Donna Dorozinsky

Greg Dorozinsky

Kristen Burke

Alycia Hannum

Brian Guza

TMF and Records Management

Administration and Operations

Just in Time GCP

Org chart

Teams

TMF and Records Management

Administration and Operations

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