Clinical Data Management

Data+ Clinical Data Management is a fully customizable Clinical Data Management System (CDMS) and Electronic Data Capture (EDC) application developed by Next-Step Tech LTD. It is designed to support clinical trials and epidemiological studies, providing the data collection, organization, and governance tools needed to generate evidence for regulatory submissions and scientific publication.

The application is used across a range of organizations including hospitals, pharmaceutical and biotech companies, contract research organizations (CROs), research institutes, and clinics.

Study Design and Database Configuration

• Build studies using a visual designer with a drag-and-drop interface
• Define the database structure according to the type of study and the data to be collected
• Supports customization to accommodate different research designs and data requirements

Data Organization and Review

• Aggregate and review data through specialized screens
• Check for data discrepancies
• Manage incomplete forms
• Track follow-ups and other data quality tasks

Data Governance and Filtering

• Reorganize the database into manageable units based on user-defined criteria
• Create filters using natural language
• Save datasets for use in reporting, workflow planning, patient management, and data analysis

Patient Engagement

• Offers a patient portal to support patient compliance and participation
• Patients can complete surveys, track their own progress, and access study insights and cross-sectional data

Compliance and Regulatory Controls

• Audit site activity
• Define and manage user roles
• Ensure compliance with clinical protocols

Data+ is part of a broader suite of applications from Next-Step Tech LTD, which also includes tools for Patient Registry, Preclinical Drug Development, Lab Management, Electronic Lab Notebook, Biobank Management, Supplementary Data Collection, Infection Control, and Patient Case Management.