The Trial Master File (TMF) is one of the critical components of a study and will be under scrutiny during audits. Having a well-constructed and managed TMF allows regulatory agencies to recreate your study from trial records and verify compliance of functional areas.
Improperly set up and managed TMFs can have significant impact that can cascade into issues such as failure to demonstrate reliability, accuracy, and integrity of trial data. This can also affect regulatory submission deadlines, cause delayed trial completion, and even result in the halt of studies.
Our Approach
Our team provides a detailed analysis of the health of your TMF, including critical gap assessments of systems, processes, procedures, plans, and SOPs. RegDev consultants leverage their vast experience and deep functional and industry expertise in all areas of the TMF to help provide audit preparedness confidence.
Gap Assessment
Preemptive Problem Mitigation
TMF Planning Strategy
TMF Management
Inspection Readiness
Post-Inspection Support
Preemptive Problem Mitigation
Our TMF remediation services provide pre-emptive mitigation of problematic areas and will help your company prioritize and execute corrections actions with timely results. Our top priority is setting you up for success, providing customized support throughout the Inspection Readiness and Audit process.
Inspection and Audit Ready
Keeping the TMF as a top priority as you develop your clinical program is paramount, not only for study metrics but also for your study budget. Ensuring the TMF is compliant with study plans and SOPs, concurrent with an active study, is equally crucial. RegDev’s proactive approach will help ensure that your TMF is consistently inspection ready and will lessen anxiety associated with inspections and audits.
Global Team
Our clients benefit from our global team of dedicated and seasoned TMF professionals. We can assist in all facets of TMF inspection readiness — from developing customized programs, training, and education to TMF set up, maintenance, and management.
Testimonial
“We would highly recommend RegDev to anybody looking to work towards inspection readiness and further develop their quality systems and processes.”
— CEO Global Pharmaceutical Company, Cambridge, MA
