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.
As the President & CEO of Just inTime GCP, Donna is responsible for running all facets of the business. She is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experiences dealing with small to large Pharma companies, academic centers, regulatory agencies, CROs, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance. She began her career in clinical research at GlaxoSmithKline where she spent 15 years in Phase I Clinical Research Operations. In 2005 Donna founded Just in Time GCP. In her capacity as President & CEO, she has created an organization that is highly respected within the clinical compliance and TMF management services industries. As a consultant, she has led many large projects performing operational gap analysis and implementing process improvement initiatives for sponsors, CROs and clinical sites. She has extensive experience in inspection readiness/preparation and has assisted organizations in developing and executing remediations across clinical systems, quality management systems, and TMF services.
Donna has presented numerous training programs in topics of GCP compliance, Quality Management Systems, Inspection Readiness, and TMF Management and is a dynamic educator. She chaired the revisions to Zone 4 of the TMF Reference Model and sits on several committees for the TMF Reference Model Working Group. Donna earned a BSN from Gwynedd Mercy University and an MSN from Widener University.
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.
As the Director of TMF Services, Jenn is responsible for ensuring Just in Time is staffed with experienced and knowledgeable team members and that they continue to receive support, training, and opportunities to provide quality services to our clients. Jenn has a passion for leading people and fostering their passions within the industry. She started her career in clinical research in document management within a large CRO where her career grew to lead a department of 150+ employees, supporting over 750 active projects with paper and electronic TMFs through migrations, rescues, set-up, maintenance, quality and delivery of the Trial Master File. Over the past five years, Jenn has supported clients in N.A., EPA, and APAC through EMA, MHRA and FDA inspections. She is actively involved with the TMF Reference Model Working Groups, attends industry conferences and has presented on panels at eXL events. Serving as a member of the leadership team with Just in Time, Jenn’s focus is on the growth and development of our staff within the TMF Services group to align with corporate strategy and our core values.
LoriAnn Verna is the Director of TMF Quality Assurance and oversees all quality activities at Just in Time GCP. 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.
Dion Boeke is a TMF Systems Manager, Validation Consultant and Certified Veeva Vault eTMF Administrator, specializing in eTMF system selection, implementation, migration, and administration. With over 15 years of PM experience and 10 years working in a clinical trial environment, Dion is well positioned to both lead projects and contribute by providing required deliverables.
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.