Clinical Trial Management (CTM)
Our Clinical Trial Management solution — designed to be a centralized Study Repository — has provisions for maintaining master entities and global objects that allow reusability across Clinical Trials. It forms the backbone of our Clinical Trial Platform, providing total control to System Administrators, Project Managers, and Clinical Data Managers to effectively maintain, manage, and monitor a study and operational database. We provide a set of tools that enables pharmaceutical organizations and CROs achieve speed and efficiency while implementing Software Solutions for their Clinical Trials.
Solution Offerings
Centralized System to Manage User Identities and Access
Our centralized User Administration service enables you to manage User Identities on our Platform and allows users to log in and access Study Resources. The unified sign-on feature simplifies access to our Platform’s various tools, facilitating Conditional Access to protect, govern, and engage with internal and external users more securely. Role-Based Authorization Control allows you to define roles centrally with granular levels of permissions that support the principles of least-privilege and segregation of duties.
Organization and
Investigation Sites Master
We help you maintain a master for all Organizations you engage with and track their involvement in different Clinical Trials. Also, you can have a centralized database that lists Warehouses, Clinical Investigation Sites, Labs, Sponsors, CROs, Retention Facilities, Statistical Service Providers, and other Vendors to avoid repetitive processes in setting up Clinical Trials.
Unified
Study Builder
Our Study Builder tools come with advanced features that allow you to define and configure the various processes and workflows needed for a Clinical Trial. Completely driven by Graphical User Interfaces — you can maintain the Study for even complex clinical trial designs including recent ones such as Adaptive Trials, Umbrella Trials, and Basket Studies. The Study Builder comes with versioning management to accommodate Study Amendments and Post-Production Changes in a centralized location within the tools, allowing targeted release across the Study, centrally or to individual Sites.
Global
Clinical Data Libraries
Our Global Clinical Data Library provides a Centralized Form Library for CRFs, CDISC Libraries for Annotations and Controlled Terminology, and a central library for maintaining the Medical Coding dictionaries from MedDRA and WHO-DD. These libraries allow Clinical Data Management teams to build a comprehensive set of objects that can be reused across Clinical Trials, thereby reducing the setup time required for each Trial. All it takes is a few clicks for these objects to be imported into the Study Data design. Additionally, SyMetric is a Gold Member at the CDISC Community.
Real-Time
Reporting
We have developed this function over the years based on our growing understanding of the monitoring needs of various stakeholders in Clinical Trials. As a result, this module provides the most comprehensive set of out-of-the-box reports that you can use directly to aid you in real-time monitoring of Studies and various other processes involved in a Clinical Trial.
Centralized Security and Compliance Manager
We firmly believe that Security and Compliance play a very important role in digital Clinical Trial Systems. Our centralized Security and Compliance Management tool on the Clinical Trial Platform allows Customers to define policies and drive security settings across various tools and modules based on their specific internal compliance and regulatory needs. Also, it comes with central auditability of data across the platform.
