Just in Time GCP
Ashley Cole is a Senior TMF Manager at Just in Time GCP, bringing extensive experience in trial master file management from previous roles at Syneos Health, where Ashley advanced from Project Specialist I to Trial Master File Lead. Prior to that, Ashley worked at INC Research, holding positions from Project Specialist I to Senior Project Specialist. Additionally, Ashley began a professional path as a Pharmacy Technician at CVS Pharmacy, demonstrating a diverse background in project management and healthcare.
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Just in Time GCP
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.