With over a 25 years of experience in clinical research operations, we assist your organization in developing processes that are regulatory compliant, yet consistent with the resourcing capabilities of your organization. We understand the complexities of small and mid size companies where resources are limited and timelines are critical.
Through our strong focus on regulatory inspection readiness, we also provide a wide range of services that help organizations achieve operational excellence and regulatory compliance. Our approach to TMF management is based on compliance, not a checklist of required records. We implement processes that meet your organizational resourcing strategy. Our TMF management team is available to support resourcing of TMF management. Whether your needs are temporary or long term, Just in Time GCP is your solution for compliant TMFs.
A Quality Management System is the cornerstone of a clinical drug development program. Just in Time GCP is the solution to all of your quality systems needs.
We help your organization harness the power of an eTMF to drive quality and ensure inspection readiness. We offer strategies for implementing a successful eTMF system.
We have extensive experience in preparing organizations for regulatory inspections. We assist our clients in preparing for the inspection, managing the inspection, and responding to regulatory findings.
Donna Dorozinsky, is the lead strategist and Client Advocate at Just in Time GCP. From the beginning, her broad background in clinical research operations was instrumental in establishing a foundation for our services. Her dynamic leadership style and approach to change management, combined with her expertise in clinical compliance and TMF systems management are the cornerstone of our organization. Donna is a frequent presenter on topics of TMF management at industry conferences and an active member of the TMF Reference Model group.
LoriAnn Verna is the Director of TMF Operations. LoriAnn is a subject matter expert in all things TMF. Her 20+ years of experience in clinical research, safety, and TMF provide her insight into client needs. She works with the client to develop processes that are efficient and functional.
Debbie Shaffer provides direct oversight of the TMF quality reviews and oversees teams across the organization. Her QC experiences ensure an inspection ready, high quality TMF for our clients. With extensive experience in the pharmaceutical and military industries Debbie will partner with you to ensure the success of your project.
Patricia Mydlow is a project manager with a specialization in clinical operations and process excellence. She has 20+ years in the pharmaceutical industry with experience in clinical development, clinical operations and process improvement, and extensive knowledge in GCP and TMF. She works with clients to develop and streamline end to end processes through a combination of scientific, operations, and business-related skills.
Brandon Butler is a TMF Systems Manager and Certified Veeva Vault eTMF Administrator, specializing in metrics/visualization-driven eTMF oversight and client optimization of eTMF platforms. With more than 10 years of experience in quality assurance and regulatory compliance, he leverages a deep understanding of the FDA regulatory scheme and appreciation for the rapidly evolving IT capabilities of eTMF platforms to create relevant, actionable reporting and process tools for client eTMF oversight.