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You may manage User Identities on our Platform and allow users to log in and access Study Resources thanks to our centralised user administration solution. The unified sign-on feature makes it easier to access the many tools on our Platform, enabling Conditional Access to more securely protect, manage, and interact with internal and external users. You can support the principles of least-privilege and segregation of duties by centrally defining roles with granular degrees of permissions using role-based authorization control.
We assist you in keeping a master for all the organisations you interact with so you can keep tabs on their participation in various clinical trials. To minimise repeating tasks when setting up Clinical Trials, you can also have a single database that lists Warehouses, Clinical Investigation Sites, Labs, Sponsors, CROs, Retention Facilities, Statistical Service Providers, and other Vendors.
With the help of our Study Builder tools’ sophisticated features, you can specify and set up the numerous workflows and processes required for a Clinical Trial. You can maintain the Study for even sophisticated clinical trial designs, including more current ones like Adaptive Trials, Umbrella Trials, and Basket Studies, because it is entirely driven by Graphical User Interfaces. Versioning management is built into the Study Builder to provide Study Amendments and Post-Production Changes in one place inside the tools, allowing for targeted release across the Study, centrally or to specific Sites.
We offer a Centralised 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 give Clinical Data Management teams the ability to create a thorough set of objects that can be used in numerous Clinical Trials, cutting down on the amount of time needed for trial setup. These objects can be loaded into the Study Data design with just a few mouse clicks.
Based on our developing comprehension of the monitoring requirements of many stakeholders in clinical trials, we have developed this feature over time. As a result, this module offers the most complete collection of pre-built reports that you may utilise right away to help you with real-time monitoring of Studies and other Clinical Trial-related procedures.
Based on their own internal compliance and regulatory requirements, Customers can design policies and control security settings across numerous tools and modules using our centralised Security and Compliance Management tool on the Clinical Trial Platform. Additionally, it includes platform-wide central auditability of data.
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum information you can provide.
