Smooth Clinical Trial Management System

Smooth Drug Development uses the most advanced electronic solutions in clinical trials.

We use a self-developed Clinical Trials Management System (CTMS), which is an essential set of tools to effectively plan, manage and track clinical trials.

Smooth CTMS is validated and is compliant with FDA CFR 21 Part 11 requirements. The system is also compliant with relevant standards, which are essential when it comes to striving for good practices (GxP). The system meets regulatory guidelines for:

  • Archiving
  • Security and access control
  • Change controls
  • Audit trails
  • System validation

Smooth CTMS is a unified platform for critically important systems needed for a clinical trial and company’s operations.

Our CTMS has a modular structure and can support company and clinical studies activities. We provide end-to-end software support for clinical trials under one roof (eTMF/eISF, EDC, IWRS, ePRO, Monitoring and Project Management tool) and support for company’s operations (QMS, LMS, HR).

Using Smooth CTMS enables users to use just one clinical trial system instead of dozens. Data sources from Sponsor, Clinical Research Organizations, site personnel and study subjects are harmonized and ingested into one single source of truth – Smooth CTMS.

The usability of the system is great because it has 1 interface, 1 login and password to all modules of the CTMS.

The system is very simple and intuitive for clinical trials professionals and young specialists.

The system is web-based so no installation is needed. Users can get access to the system at any time, from any place with access to average speed internet. Users can access the system through any browser.

The system is multilingual. Any number of languages can be added to the system upon request.

CTMS is distinguished by the use of unique technologies:

  • Tree-like Data Architecture – unlike traditional relational database interfaces, it allows you to work with all the necessary data in a single browser tab, for example, to see the data of all projects, all sites and patients, expanding only the necessary ones.
  • Go-to-Green Navigation – color driven interface helping users to better understand what actions are required in the system depending on actions of other users, the time flow and predefined deadlines.

The data in the system is constantly backed up and stored in several data centers to avoid any loss of data.

Descriptions of the CTMS modules are on the left pane.