Achieve Ongoing TMF Inspection Readiness

At GCP-Service we believe that TMF oversight, control, and inspection readiness are vital to the success of your clinical trial. Our TMF expert services are developed to support meeting these benchmarks and to reduce your TMF operational burden.
We are dedicated to an effective management of your study documentation and Trial Master Files ensuring a smooth study conduct and accelerating your clinical trial processes.

Find the right alignment of resources

An inspection ready TMF depend on the right arrangement of responsible people, processes, and TMF solutions.

Our TMF Experts operate electronic Trial Master Files and electronic Investigator Site Files. From setup to archiving, our team is here to guide you every step of the way. Whether as part of a full-service project or as a stand-alone solution we offer the following expert services:

  • TMF Consulting
  • TMF Training
  • Electronic & Paper TMF Setup & Management
  • Access to different eTMF solutions
    (low to high cost, complex to simple, etc.)
  • Electronic Investigator Site File
  • TMF Quality Control
  • Document Management
  • TMF Archiving
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Our Services

A Trial Master File reconstructs the study conduct to allow evaluation of data integrity, GCP compliance, and much more. Our Team doesn’t simply file documents into a TMF deposit, we actively consult sponsors and CROs on inspection readiness according to study milestones and manage ongoing inspection ready TMFs and ISFs.

Active TMF Management

Our TMF services include fast TMF Setup, keeping track of document life cycles, performing quality checks on multiple levels, and resolving any TMF challenges in a timely manner. Our active management approach is enforced by TMF metrics (e.g. completeness, status, document quality, etc.) derived from electronic TMFs. Together with the help of advanced technology our documents meet ALCOA principles and are fully traceable via audit trail.

QCTMS TMF

an eTMF designed to be self-intuitive & cost-effective

QCTMS TMF is developed to meet all regulatory requirements (e.g. audit trail, user-role permissions, etc.). It provides study oversight, control and contributes to TMF inspection readiness. It is intuitive to use and has all the necessary tools to allow efficient management of study documentation.

A core feature of QCTMS TMF is its integrated electronic Investigator Site File helping to push your clinical trial to the next level. Clients can profit from various benefits, such as:

  • Fast & Central accessibility
  • Operational Efficiency
  • TMF Reporting
  • Guided TMF reconciliation
  • Improved (Remote) Monitoring
  • Reduced (monitoring) costs
  • Reduced archiving efforts for sites and sponsors
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