Product Overview
Sitero Mentor eTMF clinical trial software can get up and running quickly and efficiently. Built on the same platform as Mentor CTMS and available with affordable add-on pricing, it maximizes value, minimizes headaches, and meets all regulatory requirements, with support for the most recent DIA Reference Model, 21 CFR Part 11 compliance, or a complete audit trail.
Sitero offers a full range of EDC options, from complete SaaS to Full Service, all built on a single, best-in-class platform that’s been successfully used by leading Sponsors and CROs and proven across thousands of clinical trials worldwide.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
Sitero confronted and overcame unexpected challenges while integrating eTMF functionalities into an existing CTMS solution. Recognizing the value of combining these capabilities, the team embarked on a mission to develop a comprehensive solution maximizing efficiency and usability for the user community.
We quickly realized that organizations only need core eTMF functionality, such as secure document storage, and not an additional system running in parallel to their already deployed eClinical solutions, which requires troublesome custom integration(s). Furthermore, organizations needed eTMF capabilities at a much lower price point than currently offered by other standalone systems. This, of course, led to carefully considering, would a more streamlined approach provide significantly more value? This question started a discovery process involving numerous, in-depth discussions with regulatory, clinical trial, and documentation experts about the absolute must-haves for an eTMF solution as well as how those could be best implemented in an easy-to-use framework.
About the company
Today, Sitero is a next-generation clinical trial solutions partner, working with more than 200 Pharmaceutical, Biotech, and Institutional Research Organizations globally. Sitero uses technology to drive safety, compliance, quality, and efficiency in research and clinical trials, so customers can bring life-changing treatments to market safer and faster.
With leaders in Technology, Clinical Operations, Biosafety, Drug Safety, Ethical Review / IRB, and more, Sitero draws on a deep well of knowledge to build solutions for customers. As a technology and service-oriented partner, Sitero focuses on forging strong relationships that can drive efficiency by leveraging next-generation software.
The company’s continued innovation is driven by its core mission: To advance clinical research with a next-generation, technology-enabled delivery model.
