Clinical Trial Management (CTM)

Our Clinical Trial Management solution provides features for managing master entities and global objects that enable reuse across Clinical Trials. It serves as the foundation of our clinical trial platform and gives system administrators, project managers, and clinical data managers complete control over a database so that they may successfully administer a study and conduct operations. We offer a suite of tools that help pharmaceutical companies and CROs install software solutions for their clinical trials quickly and effectively.

Centralised User Identity and Access Management System

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.

Organization and Investigation Sites Master

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.

Consolidated Study Builder

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.

Libraries of clinical data

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.

Reporting in Real Time

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.

Security and Compliance

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.

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