Leveraging advanced technology for efficient study management
Clinical trials produce an enormous amount of documentation that needs to be created, managed, and organized throughout the study lifecycle.
The demands from regulatory agencies and the drug development process at large make it essential that your study documentation is easily accessed, efficiently managed, and thoroughly organized.
At ethica CRO, our eTMF platform is built to:
By working with a quality Electronic Trial Master File (eTMF), you can avoid the hassle of paper-based filing and instead organize your data in one centralized location while being able to share the necessary data with all relevant stakeholders.
At ethica CRO, our leveraging of eTMF software minimizes TMF maintenance costs, optimizes document security and accessibility, and guarantees audit readiness.
We employ eTMF Connect, Montrium’s state-of-the-art platform.
Designed using the TMF Reference Model, eTMF Connect centralizes and standardizes your clinical records enabling both ethica CRO associates and Sponsors to contribute and access clinical documents and information in real-time. We can also configure the platform to allow direct access to inspectors after minimal training.
During the study start-up process, ethica CRO’s highly qualified associates will provide Sponsor and sites with the appropriate level of targeted training so that all stakeholders can benefit from the following key platform features:
Project teams and clinical operations managers can be provided with precise visibility on eTMF completeness, quality, and timeliness.
We can create custom roles for the entire clinical team and define their level of access and permission.
We can provide you with visual views on real-time completeness based on study, country and site milestones.
Our platform combines comprehensive clinical eTMF functionality, advanced collaboration features, and complete scalability to create a dynamic, intuitive and powerful eTMF solution that provides unparalleled benefits and value.
