Trial Master File & Document Management
Achieve Ongoing TMF Inspection Readiness
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:
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 (+)
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: