With over 100 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.
With over 20 years experience in the drug development industry, Ashley leads all activities related to business operations at Just in Time GCP. Ashley is a Resourceful and dynamic Account Leader offering hands-on management, technical, and clinical experience driving strategic programs and continuous improvement initiatives aligning to client vision. Forward-thinking, solutions-oriented leader proficient at building and coaching cross-functional teams and cultivating strong partnerships within key accounts. Maintain a constant eye on the big picture, focus on critical details, and effectively manage multiple priorities in challenging, fast-paced accounts. Committed to adding value & exceeding expectations through insightful analysis, sound business judgement, collaborative problem-solving, disciplined decision-making, and a proactive lead-by-example style.