Donna Dorozinsky, President & CEO
“By failing to prepare, you are preparing to fail.”
This axiom by Benjamin Franklin holds true for the inspection readiness of a clinical trial.
The thought of a possible regulatory inspection can be stressful. Regulatory inspections are performed to ensure data integrity and to evaluate if a clinical trial was conducted in compliance with the protocol, study plans, Good Clinical Practices (GCP) and applicable regulations. Inspection readiness is the current buzzword in the industry, especially for the Trial Master File (TMF). For true inspection readiness, an organization must begin with the end in mind developing processes and plans that support regulatory compliance through-out the trial. They need to ensure that activities are well documented in the Trial Master File (TMF). Unfortunately, many organizations do not prepare for inspection readiness from the start. Whether it is because of limited resources or lack of planning, the failure to prepare leads to a stressful process.
Just in Time GCP is a boutique consulting company that can help take the stress out of TMF Management and Inspection Readiness. Just in Time GCP prides themselves on being an organization that takes operational challenges and turns them into operational excellence. The company’s wide range of services include implementation and management of clinical systems, TMF management services, Quality Management System (QMS) implementation, and Regulatory Inspection Readiness and Preparation. Their team of experts offer solutions that are tailored to the individual client. They can provide as much, or as little expertise as needed.
Organizations today cannot risk approval delays or non-approval because they are ill-prepared for a health authority inspection.
We help organizations implement systems and processes that support regulatory compliance which results in inspection readiness
Just in Time GCPs services include providing inspection preparation for organizations. They set themselves apart from other TMF services companies with their team’s extensive experience with health authority inspections and their focus on ensuring that the TMF represents the story of the study. They support clients in finding and understanding their inspection risks, developing storyboards to address these risks, ensuring a complete TMF, and preparing investigator sites. “We help organizations implement systems and processes that support regulatory compliance, which results in inspection readiness,” states Donna Dorozinsky, President and CEO of Just in Time GCP.
As a part of the Quality Management System (QMS) service, Just in Time GCP develops business processes, prepares supporting training tools and procedural documents, and performs vendor and site audits. They assists pharmaceutical companies in implementing quality management systems by writing and developing regulatory compliant procedural documents and templates for all aspects of R&D, thus imparting compliance.
Clinical systems need to be validated and be 21 CFR Part 11 compliant. Just in Time GCP has expertise in helping organizations understand what that means. There are many “off the shelf” systems available which are validated systems, so a company assumes no further action is required on their part. Nothing could be further from the truth. Getting a system is just the first step.
Just in Time GCP can perform validation of clinical systems in their operating environment. They also help organizations implement processes that support the systems and ensure that these systems are configured to meet the client’s business needs. Post configuration and validation, the company supports the clients with a range of services for the ongoing maintenance of the system, including managing user access, providing user training, study configurations, managing change control, evaluating software updates and enhancements, and ensuring that updates in the system result in updates to process and user training.
When it comes to TMF management and services, Just in Time GCP is there to help organizations harness the power of an eTMF to drive quality and to ensure inspection readiness. To do so, they offer proven strategies for implementing a successful eTMF program. The company assists both small, medium, and large organizations in ensuring that their TMFs are inspection ready. Whether the TMF is held by the CRO and the sponsor has responsibility for oversight activities, or the sponsor is holding the TMF, Just in Time GCP has a team that will support TMF management. Their team of TMF Leads, TMF Managers, TMF Specialists and Document QC Reviewers can be a short-term solution to resourcing needs or a long-term solution to a study team. They can integrate into a client’s organization as a member of their study team and manage all aspects of the TMF from document quality checks to TMF completeness reviews to management of EDLs.
Just in Time GCP has evolved from a small consulting firm established in 2005 to a high-value service provider. Their team’s depth and breadth of clinical compliance experience to ensure that their clients are prepared to face the challenges of a regulatory inspection. The company’s success is exemplified with clients that have been with them for as many as 10 years. Donna concludes, “We view our staff and our clients as family, and it is this focus on the family that builds long term relationships of trust.”