With over 75 years of combined experience in clinical research operations, our Leadership team can 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 in Time GCP, Donna is responsible for running all facets of the business. She is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive 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 and biotech 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 is a member of the TMF Reference Model Steering Committee, a member of Association of Women Entrepreneurs, and honored to be a Founding member of Society of Nurse Scientists, Innovators Entrepreneurs, & Leaders. Donna serves on the Board of Trustees at Gwynedd Mercy University where she received her BSN and also has an MSN from Widener University. Donna is a frequent presenter at conferences and workshops speaking on topics related to Clinical Compliance, Inspection Readiness, and TMF management.
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 and Operations, 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 at 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 continued growth and development of our company, corporate strategy and core values.
As Director of Quality and Compliance at Just in Time GCP, LoriAnn is responsible for overseeing all components of quality. In addition, she is responsible for process development and improvement for the company and serves as an internal Subject Matter Expert for all things TMF. She assists the client with development of processes that are efficient and compliant. LoriAnn has over 25 years of experience in clinical research which includes clinical operations, safety, and TMF management. Her experience dealing with small to large Pharma and biotech companies, as well as investigator sites, provides her with the knowledge to assist research organizations in all areas of clinical compliance, focusing on eTMF and Inspection Preparation. She is a member of the TMF Reference Model and was a member of the email Communications Subgroup which recently released the “Guidance for the Management of e-Mail Communications in Clinical Studies”. LoriAnn has a Bachelor of Science in Nursing from Penn State University.