CDMS Software: What to Know for Your Clinical Trials

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Contributing Expert: Rod McGlashing, Data Science Subject Matter Expert at Medrio

A Clinical Data Management System (CDMS) is essential for running efficient, compliant clinical trials. CDMS software helps research teams collect, clean, and manage trial data. 

In this blog post, you’ll learn:

• How is a CDMS defined?
• What is clinical data management?
• What are the stages of data management?
• How are EDC and CDMS software different?
• Why use a CDMS in clinical trials?
• Who uses a Clinical Data Management System?
• What are the benefits of CDMS?
• What regulatory compliance factors should you consider?
• What features should you look for in CDMS?

What Is CDMS?

CDMS stands for Clinical Data Management System. It is a software that manages and stores clinical trial data. A CDMS is often paired with an Electronic Data Capture (EDC). 

A CDMS/EDC is an essential part of data collection, management, and analysis. It aids in data collection, lab management, medical coding, data review, data cleaning, query management, and risk management.

What Is Clinical Data Management?

Clinical data management is the process of reviewing, cleaning, and managing data generated during a clinical trial. This process ensures clinical trial data is accurate and compliant with regulatory standards. 

Clinical data management services support clinical research integrity through data cleanliness and compliance. The help from an expert team enables sponsors and CROs to more quickly make informed decisions and bring effective treatments to market.

Learn more about Medrio’s clinical data management services.

Clinical Data Management Stages 

Clinical trial data management follows a structured process to ensure accuracy, completeness, and regulatory readiness. 

Data management stages typically include:

• Study setup. Designing the database, building forms, and defining data standards.
• Data cleaning. Running checks, resolving queries, and validating entries to ensure accuracy.
• Data review. Ongoing review of data for consistency and protocol compliance.
• Local lab management. Converting lab results from various sites into standardized units and reference ranges.
• Medical coding. Standardizing adverse events and medications to ensure consistency and support regulatory review. 
• Database lock. Finalizing the dataset once all queries are resolved and the data is clean.
• Data export and analysis. Preparing data for statistical review, regulatory submission, and reporting.

Need data management support? Explore Medrio’s clinical data management services.

EDC vs CDMS Software

An Electronic Data Capture system (EDC) in clinical trials collects clinical trial data. 

A CDMS is typically a broader system, which should include an EDC, that manages and stores clinical trial data.

Learn more about the basics and benefits in this EDC in clinical trials blog.

Why Use CDMS in Clinical Trials?

A Clinical Data Management System (CDMS) serves as the backbone of modern clinical trials. 

This clinical trial data management software offers a centralized, secure, and efficient way to manage trial data. It ensures data accuracy, streamlines operations, and supports compliance with regulatory requirements. 

Here are the primary functions of a CDMS:

• Data collection. Captures patient and trial data electronically, replacing error-prone paper-based methods and enabling real-time access to information.
• Data cleaning and validation. Uses edit checks, queries, and logic rules to detect and correct inconsistencies, ensuring data quality and reliability.
• Data integration. Combines data from multiple sources, such as labs, EHRs, and ePRO systems, into a single, cohesive platform for analysis.
• Local lab management. Converts lab results from different sites into standardized units and reference ranges to ensure accurate analysis.
• Medical coding. Standardizes medications and adverse events using controlled vocabularies to support regulatory review. 
• Data review and monitoring. Enables teams to track data in real time, monitor site performance, and ensure protocol compliance. 
• Audit trails and compliance. Maintains detailed logs of changes and user activity to support regulatory compliance and data integrity standards.
• Reporting and visualization. Generates reports and dashboards to help teams track enrollment, monitor safety, and make informed decisions.
• Database lock and export. Prepares and locks clean, validated data for statistical analysis and submission to regulatory authorities.

Who Uses a Clinical Data Management System?

CDMS is essential for any team conducting clinical research. This software is used by many study team members to streamline their tasks.

Here’s a look at who typically uses a CDMS:

• Sponsors. Pharmaceutical, biotech, and medical device companies use CDMS to manage clinical trial data and trial progress across sites and studies.
• Clinical Research Organizations (CROs). CROs rely on CDMS to manage data collection, cleaning, and reporting on behalf of their clients.
• Research Sites. Participating sites enter and review trial data within the CDMS, ensuring timely and accurate documentation of trial activities.
• Clinical Research Associates (CRAs): These team members use CDMS for source data verification (SDV) and to address data quality concerns. 
• Data Managers. These specialists use CDMS to design databases and ensure the quality and consistency of trial data.
• Medical Coders: Coders use a CDMS for consistent reporting of adverse events, medical history, and concomitant medications.
• Biostatisticians. These study team members use CDMS outputs to perform statistical analyses, enabling informed decisions about a treatment’s safety and effectiveness.

Benefits of CDMS

Not all CDMS are the same. But a system with an intuitive design and flexible functionality can enable efficient, higher-quality clinical trials. 

An intuitive CDMS partner can help you:

• Speed up clinical trial timelines. Accelerates trials with fast builds, standard forms, reusable templates, and simple mid-study updates.
• Support flexible workflows. Customize workflows to match the needs and complexities of various trials.
• Maintain submission-ready data. Streamline regulatory submissions with standardized formatting and complete datasets.
• Improve data accessibility. Provide stakeholders with centralized, easy-to-navigate data customized to their individual roles. 
• Maximize operational efficiency. Automate tasks and get rid of redundancies to save time and resources.
• Capture high-quality data. Eliminate errors and ensure accuracy with configured edit checks and query management tools.
• Ensure regulatory compliance. Be ready for audits with systems designed to meet global regulatory standards. 
• Make decisions based on real-time data. Access live dashboards and retrieve dynamic reports seamlessly.
• Enhance data integrity. Maintain clean, reliable data with robust security and audit trail features.
• Optimize data analysis. Access advanced reporting and data exports for better insights.
• Scale clinical trial efforts. Expand capabilities easily to handle large datasets, run more studies, and add more sites.
• Transition between study phases. Move to the next phase with quicker study builds based on form templates.

Regulatory Compliance for CDMS System

Clinical trials must comply with relevant regulations or face failure. Savvy sponsors and CROs rely on their providers as trusted partners in achieving regulatory compliance. 

Your CDMS should be compliant with:

• E6 (R3) Good Clinical Practice
• ISO 9001
• Annex 11: Computerised Systems
• General Data Protection Regulation (GDPR)
• Health Insurance Portability and Accountability Act (HIPAA)
• FDA 21 CFR Part 11
• SOC 2 Type II
• ISO/IEC 27001
• ISO/IEC 27701
• EU-US Data Privacy Framework Certified

Learn more about each of these standards is this clinical trial data security blog.

What to Look for in Clinical Trial Data Management Software

Each study requires the right mix of purpose-built technologies. However, there are some basic features that every clinical trial needs for its success. 

Your CDMS solution should support the following: 

• Real-time and secure access to clinical trial data
• Efficient data capture options with both onsite and remote capabilities
• Consolidated reporting with dynamic reports and easy data exports
• Integration of third-party data sources 
• Comprehensive data and privacy protection features
• Simple and efficient mid-study updates 

Want to know more about what to look for in CDMS? Download this CDMS clinical trial guide for a full checklist.

About Medrio CDMS/EDC 

Medrio’s CDMS/EDC is easy to use and quick to learn. Our solution creates efficiencies for all study team members. You can conduct efficient trials, handle increases in data volume, support high-quality data, and add new sites with ease. 

Control over your data combined with real-time reporting means you can react quickly to changes and pivot without delays. Plus, our CDMS/EDC solution is built on a unified platform that easily integrates with our other solutions, including eCOA/ePRO, eConsent, and RTSM.