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Develop a Culture of Inspection Readiness with TMF Guidance
Trial Interactive provides the TMF guidance and resources you need to stay compliant. Join the thousands of clinical research professionals who use our TMF services to reduce TMF management burdens, avoid inspection findings, and streamline inspection readiness.
Maintain global regulatory compliance.
Work with TMF experts who have FDA, EMA, PMDA and MHRA inspection experience on SOP and process development, TMF Reference Model implementation, TMF best practice and inspection readiness workshops.
Ensure TMF completeness and data quality.
Avoid potential issues with your studies through TMF guidance on quality reviews and TMF health checks that proactively identify and correct documentation and indexing issues.
Simplify TMF document management.
Work with experts for TMF document scanning, naming, indexing, TMF migrations, eTMF archiving and more.
Access the first and only accredited TMF University.
Certify your managers, leaders, and specialists in best practices with the only accredited TMF University in the world.
Ensure Quality, Completeness, and Health with Trial Master File Services
All students attending this real-time, collaborative, online university will take synchronous, instructor-led courses. Each course is three hours long. Each learning level consists of three, 3-hour modules for a total of nine hours of course instruction within the learning level. TMF University offers four cohorts a year with conveniently scheduled training sessions for professionals. Schedule a Call >
All students begin with the Level 1 - Discovery accreditation led by industry experts. Developed for those currently working in the TMF, the Discovery classes will provide learners with a solid foundation of TMF fundamentals. Upon completion of Levels 1 & 2 you can earn the status of Qualified TMF Associate. Successfully completing all three levels will result in the Qualified TMF Manager status. Schedule a Call >
TMF University offers a more robust, involved program where individuals walk away with professional credentialing. Individual learners attend courses, complete individual competency assessments, and receive individualized comments from assessors through a feedback loop until they pass the assessment. Schedule a Call >
Small classroom sizes and regular weekly meeting times allow for courses to be highly collaborative. Learners can easily interact with instructors for feedback and ask questions in real time. They can also interact with colleagues from other organizations to hear firsthand how other TMF stakeholders are working in the TMF space. Schedule a Call >
Cohort sizes are limited to ensure students have the opportunity to collaborate with instructors and industry colleagues for TMF guidance. Schedule a Call >
All TMF University courses are accredited by The International Accrediting Organization for Clinical Research (IAOCR), the world’s only organization that qualifies Clinical Research Professionals to international standards. Additionally, our instructors and our assessors are formally accredited and credentialed through the IAOCR. Once students complete the competency assessments, they will receive accreditation and credential statuses based on the number of courses they complete. Schedule a Call >
Corporate training and education is designed for organizations looking to train their TMF management team or train their general TMF stakeholders. Typically, organizations will sponsor corporate training workshop(s) for their team. Schedule a Call >
Organizations can choose from 15 out-of-the-box courses and have the ability to modify course topics and length to meet their needs. Our TMF experts team works with organizations to customize the course with company-specific information such as SOPs, resourcing models, eTMF systems, and more. Schedule a Call >
Workshops can either be live, instructor-led training via Zoom, or live on-site. Learners have the option to participate in knowledge checks and brief exercises, but will not complete a formal assessment. At the end of the workshop, participants will receive a certificate of attendance. Schedule a Call >
Corporate training workshops are entirely customizable. If an organization sees their stakeholders struggling with a particular area in TMF management, we can focus on that specific area. Common knowledge gaps include document QC, TMF QC, inspection readiness, and general TMF overview. Schedule a Call >
Corporate training benefits TMF stakeholders who may not work with the TMF everyday but need TMF guidance to know the overall importance of the TMF for larger business operations. Learners will gain introductory knowledge about the TMF, why it’s important, and why stakeholder engagement matters. Schedule a Call >
Corporate education is flexible and provides the ability for organizations to tailor and modify training content to meet their unique needs and knowledge gaps. Learners are not required to take assessments or follow structured course content. Schedule a Call >
The Features for Compliant, Inspection Ready Trial Master Files
TMF Management
- Document processing in any system
- TMF study owner resources
- TMF quality review, document Quality Control, and completeness/gap analysis
- Paper scanning, naming, indexing, filing services, etc.
- TMF migrations and archiving
- Inspection readiness and audit support
- Metrics and KPI development
TMF Consulting Company
- Best practice workshops
- Inspection readiness workshops
- SOP and Process development and review
- TMF Reference Model Implementation
- TMF Plan creation
- Metrics and KPI development
- FDA, EMA, PMDA and MHRA inspection experience
- WCG Metrics Champion Consortium
- Barnett International Certified
TMF Education
- The world’s first and only accredited TMF University
- Multiple accreditations and certifications
- Corporate training programs
US-Based Biopharmaceutical Company With Over 350 Employees
This company was looking to reconcile a phase III study with over 450 global sites.
A large biopharmaceutical company in the middle of a pivotal phase III study, run by seven CROs and vendors, needed help with over 150,000 paper documents across their 450 global investigative sites. They turned to TransPerfect trial master file services for scanning, coding, and TMF inspection readiness expertise to help process their TMF documentation.
What's My TMF Inspection Risk?
85% of studies are delayed, and inspection findings are often a factor. Calculate your TMF Inspection Risk Score™—and know how to improve it — in less than 10 minutes.
