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Electronic Trial Master Files

Premier Consulting eTMF solutions facilitate clients’ data and document management for clinical trials. Premier Consulting administers the eTMF, which includes setup, processing, maintenance, and quality control of clinical trial documents for archiving and transfer to the sponsor. Our quality control process checks for document completion, accuracy, relevant signatures, and duplications. Premier Consulting’s eTMF team ensures the eTMF for each study is current and provides status reports to track outstanding or expiring documents. Upon completion of a study, the eTMF team performs a final quality check prior to archiving and creates an audit report.

Services

What is your clinical trial master file situation?

  • Held hostage by not having access or knowing what you have in the TMF
  • Unbudgeted resource hours for reconciliation of TMF
  • No real-time sponsor oversight
  • Looking for missing documents at end of study
  • Turnover of staff overseeing the TMF
  • Having trouble seeing what’s missing from the hard-copy TMF
  • Lack of fireproof storage space for paper copy
  • File nomenclature inconsistencies
  • Misfiled documents
  • Difficulty transitioning from hard copy to electronic files
  • Lack of document version control
  • Unprepared for regulatory inspections

Premier Consulting’s eTMF team can manage your TMF and provide continuous quality oversight throughout the lifecycle of your study. Sponsors can view the files and monitor the activities as much as they want. And quickly launching a new study will require no special programming.

Once the study is set up, Premier Consulting performs consistent quality review in parallel – not quarterly or biannually. Using the SureClinical eTMF software, Premier Consulting can provide validated, FDA-approved digital signing for sponsors, investigators, and the clinical team.

More ways to benefit from Premier Consulting eTMF services

  • Drag and drop files for easy upload
  • Save documents in their original source format along with an automatic PDF conversion
  • Track and monitor file discrepancies for completion or resolution
  • Send reports automatically to clinical trial managers, clinical research associates, project managers, or any other clinical team member
  • Provide file inventory and discrepancy reports to monitors, so they can see what is in the file for each site, what is outstanding, and which documents have issues
  • Enable regulatory agencies or an internal sponsor team to perform study file audits externally with the validated, audit-ready SureClinical system

Premier Consulting’s eTMF team is ready to assist your clinical team with real-time oversight of your clinical study trial master file. Please contact us to learn more about our eTMF services and integrated regulatory strategy solutions.