Our consultants are experts in GCP compliance and TMF Management. We work with organizations to implement quality management systems that ensure a quality clinical trial. The Trial Master File (TMF) is a collection of documentation that demonstrates the trial was conducted to the study plan and in compliance with GCP and regulations. A poorly managed TMF or a TMF with gaps puts an organization at risk during a regulatory inspection.
Just in Time GCP works with your team to ensure an inspection ready TMF to help minimize these risks. Our team is familiar with the risks of an incomplete TMF in the face of a Health Authority inspection.
Our services in areas of systems implementation, process development, TMF management, training, and audit ensure your organization is confidently prepared for any inspection.
Our services and processes include:
Quality Management System
A Quality Management System is a collection of business processes supported by training and audit. We work with our clients to develop processes and prepare supporting procedural documents. We develop the supporting training tools to ensure quality is the cornerstone of your organization’s commitment to quality and subject safety. Our experienced auditors perform vendor and site audits to ensure you are aware of potential risks.
We take the stress out of TMF management. As your trusted partner, we help your organization harness the power of an eTMF to drive quality and to ensure inspection readiness. To do so, we offer our proven strategies for implementing a successful eTMF program. We can assist you in implementing a new system, migrating from one system to another, or remediating a current system. We can assist with everything from identifying and configuring a system that meets your business needs, implementing an “out of the box” system, assisting with the validation process, and developing processes for implementation and use of the system.
Our team of Project Leads, TMF Managers and Specialists can be a short term solution to resourcing needs or a long term solution to your study team. Our Project Leads will integrate into your organization as a member of your study team. They will manage your expected documents, make TMF set up changes, and manage user access. They will work with your study team to develop TMF Plans and conduct ongoing risk based completeness reviews. We work with your other partners in gathering TMF content and ensuring that your have an inspection ready TMF. Our document reviewers can upload and classify your content and perform record quality checks.
We are experienced auditors. If you are planning for an upcoming inspection or just want to assess the completeness of your TMF managed by your CRO, our team can conduct a GCP audit of the TMF. We can review your processes, inspect your TMF, interview staff members, or visit a site for a site assessment. Our auditors will identify any issues or areas for improvement and then work with you to help achieve site and vendor compliance in addressing these issues.
We assist sites in implementing Quality Management Systems and optimizing existing processes. We have experience working with individual sites or with health systems to ensure compliance with regulations and GCP while keeping in mind their individual site challenges.
Today companies are developing assets with minimal sponsor resources and partnerships with multiple vendor organizations. Although many services are outsourced to vendors during a clinical trial, the Sponsor is ultimately accountable. Sponsor oversight is critical to conducting quality research and managing an asset. Our clinical operations team works with Sponsors in developing and implementing processes that support quality operations and sponsor oversight activities. We review current processes, identify gaps, and provide recommendations for new processes or optimizing current processes. We provide input into establishing vendor expectations and then maintaining sponsor oversight during a trial.
Organizations today cannot risk delays or non-approval because they are ill prepared for a health authority inspection. Just in Time GCP has extensive experience in preparing organizations for regulatory inspections. We are there to assist our clients in preparing for and managing the inspection. We support our clients in understanding their inspection risks, developing storyboards, training their teams, and preparing their investigator sites.
Appropriate training is another essential component of a quality program. Training needs are multi-fold including everything from general GCP training to study-specific training. Training is a core component of a Quality Management System. The best processes don’t work if the team does not understand or follow them. We provide training for your clinical operations team or study team and our programs are customized to meet your needs. We set up the structure for you to perform the training or we provide the actual training programs.