Is this your Clinical Trial Master File situation?
- Held “hostage” by not having access or knowing what you have in the Trial Master File (TMF)
- Unbudgeted “man-hours” for reconciliation of TMF
- Sponsor oversight not in “real time”
- Retrieving missing documents at end of study
- Turnover of staff to oversee the TMF
- Hard copy TMF difficult to see what’s missing
- Lack of storage space for paper copy (no fireproof cabinets or fireproof room)
- File nomenclature inconsistencies
- Documents misfiled
- Hard copy to electronic files difficult transition
- Lack of document version control
- Unprepared for regulatory inspections
RPI’s eTMF team can provide the service to manage your TMF and provide quality oversight continuously throughout the lifecycle of your study. The sponsor will have access to view the files and monitor the activities as much as they want and a quick start-up to launch a new study requires no special programming.
Once the study is set-up, consistent quality review is performed by RPI in parallel (not quarterly or biannually). Using the SureClinical eTMF System, RPI can provide validated FDA-approved digital signing for sponsors as well as investigators and the clinical team.
Additional beneficial services and features include:
- Easy “drag-and-drop” feature for files to be uploaded
- Documents in their original source can be saved as well as an automatic pdf conversion of the document filed
- File discrepancies can be tracked and monitored for completion or resolution
- Automatic reports can be provided to CTMs, CRAs, Project Managers or any other clinical team member
- File inventory and discrepancy reports are great tools for monitors to see what is in the file for each site and what is outstanding or what documents have issues
- SureClinical validated system is audit-ready. Study file audits can be performed externally by regulatory agencies or an internal sponsor team.
RPI’s eTMF team is ready to assist your clinical team with “real time” oversight of your clinical study Trial Master File. Please email us with your inquiry at firstname.lastname@example.org to learn more about RPI’s eTMF service and integrated regulatory strategy solutions