TMF Consulting

Our career TMF professionals provide hands-on support for managing your TMF from initiation to closeout. We conduct gap analyses, plan and build TMF processes and eTMF systems, and ensure accurate filing and indexing according to the CDISC TMF Reference Model. Whether you’re new to eTMF or need extra support, our team handles the complexities of global compliance, allowing your ClinOps teams to focus on trial execution.

TMF completeness issues can jeopardize inspection outcomes, especially when dealing with numerous international regulations. Our TMF services experts step in to review and rescue at-risk TMFs, addressing gaps in documentation before critical inspections. With experience in global compliance restoration, we prepare your TMF for submission, minimizing risks of preventable findings and delays.

Our consultants go beyond ongoing TMF management by delivering comprehensive inspection readiness solutions. We conduct best practice workshops and pre-inspection reviews, confirming your TMF is complete, compliant, and aligned with global standards. With expertise in FDA, EMA, PMDA and MHRA regulations, we guide your study teams through gap analyses, GCP inspections, mock audits, and completeness checks. We help you stay inspection ready across multiple jurisdictions.

Our consultants assess your clinical trial's unique needs to optimize document workflows and implement customized solutions. This process includes advanced automation for document version control, standard operating procedure (SOP) development, and personalized dashboards that track TMF health in real time. With deep knowledge of global regulatory standards such as 21 CFR Part 11 and EMA GCP, we transform ClinOps processes to meet the growing demands of international compliance.

We offer ongoing risk based TMF oversight with regular risk assessments and updates, helping you identify potential issues early. Our approach to continuous, periodic review ensures that your TMF remains inspection ready and compliant with global regulatory standards throughout the trial lifecycle.

We assist sponsors and CROs in establishing ongoing TMF governance practices that align with global regulatory frameworks. Our consultants help you implement good clinical practices, create procedural documents, and verify that your current SOPs meet the requirements of international bodies such as the FDA, EMA, and MHRA.

Our experts lead seamless eTMF migration and setup for pharmaceutical, biotechnology, and medical device organizations. As a pioneer in eTMF solutions, we have proven expertise helping thousands of companies modernize their approach to clinical trial digitization.

Our TMF / eTMF archiving services are supported by a global team of clinical trial translation experts. Together, we provide the multilingual support you need to comply with global regulatory requirements from agencies such as the EMA and MHRA. Working in harmony with your unique systems and processes, we can deliver the language services your team needs to stay focused on clinical trial operations.