Implementing a Clinical Data Management System (CDMS)

Implementing a Clinical Data Management System (CDMS)

Clinion Team

Clinion – Clinical Data Management System

We at Clinion understand how clinical data can completely impact the cost, effectiveness and turnaround time of any clinical study.

Clinion’s Clinical Data Management System (CDMS) works towards storing and managing EDC and Paper-based data of clinical studies. The clinical data gathered as a result of the investigative process is stored in CDMS.

Clinion’s CDMS is responsible for collecting, cleansing and maintaining accurate, high-quality data compliant with all regulations. The key function of our CDMS is to reduce the errors in data handling and make it qualified for analysis in minimum cycle time.

Clinion-Complete Solutions for Data Management

For any clinical trial, CDMS data is critical as it can make or break the CDMS project in terms of results, costs, and time. As the demand for pharmaceutical products increases, accurate data that meets the quality assurance standards is imperative in the drug evaluation process.  

The steps in Clinion CDMS to produce feasible, scalable and error-free clinical data are:

Data Design

Data design involves creating multiple studies through logical steps using various design tools such as eCRF Designer and Global Library. The complete CRF is generated dynamically by the system based on the study configuration. The driving standard for this is the clinical trial protocol and the Case Report Form (CRF).  

Data Entry and Capture

Data entry occurs as per the clinical data management process. The eCRF controls data entry, validation, changes, updates, deletions, and edition. All these are monitored and tracked by the CDMS. 

Data entry access is controlled and verifiable. Data entry is also immutable – all changes are tracked and can be retrieved at any point in time, making the system compliant with FDA guidelines. 

Data Management

Form design and validation checks are key to data consistency and reducing data discrepancies. Various tools like edit checks, source document verification, query workflow, dashboards, AE/SAE reports are available to data managers to ensure high-quality data capture and storage. Accurate validation checks are mandatory in Clinion CDMS.

How our solutions help accelerate clinical trials

Our CDMS system improves the productivity of clinical studies significantly by:

Setting up a Clinical Study in days instead of weeks or months

We have simple, robust, user-friendly application interfaces that allow users to quickly configure forms and edit checks and publish the site to production for data capture. 

No compromise on Data Accuracy

While our system provides user-friendly data forms for rapid data entry, we leave no scope for inaccuracy. There are manual and auto edit checks throughout to ensure the correctness of data.

The key features of Clinion CDMS are:

  • Enables quick clinical study setup
  • Captures robust and accurate data
  • Maintains data accuracy through edit checks, source data verification, querying reports and alerts and notifications.
  • Helps monitor real-time data
  • Ability to integrate with CTMS, IWRS, CDISC, and other applications
  • Simple to set up and implement
  • Effortless data sharing made possible through our Cloud-based system

We, at Clinion have over a decade of expertise in providing clinical trial solutions to pharmaceutical, biotech, and medical device companies. Our innovative technologies and advanced clinical data management solutions have streamlined and optimized clinical studies significantly.  

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