RPI’s eTMF solutions facilitate clients’ management of data and documents for clinical trials. RPI administers the eTMF, which includes the set-up, processing, maintenance, and quality control (ensuring document completion, accuracy, relevant signatures, and duplications) of clinical trial documents for archiving and transfer to the sponsor. RPI’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 final archiving and an audit report is created
Is this your Clinical Trial Master File situation?
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 Software, RPI can provide validated FDA-approved digital signing for sponsors as well as investigators and the clinical team.
Additional beneficial services and features include:
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