EDC

SyMetric's Electronic Data Capture (EDC) tool is a web-based platform designed for clinical data management in clinical trials. It allows users to set up and configure study databases, design Case Report Forms (CRFs) with programmed edit checks, collect clinical data, and extract submission-ready standardized datasets through a graphical user interface.

The platform is aimed at clinical data management teams and investigation sites that need to capture high-quality, accurate data in line with regulatory standards. Its agile approach to study database configuration is intended to reduce setup time across the trial lifecycle.

eCRF Management

• Supports design and configuration of Case Report Forms (CRFs)
• Enables programming of real-time validation checks to support data quality
• Facilitates collection of complete and accurate data in accordance with regulatory standards

Source Data Verification

• Provides a selective Source Data Verification (SDV) process focused on critical study data points rather than 100% SDV for all patients
• Designed to reduce time, effort, and costs while maintaining scientific and ethical integrity of the trial
• Supports data quality and conformance to source data requirements

Query Management

• Includes a Discrepancy Management tool to help investigation sites identify and manage data aberrations
• Supports clean and consistent data capture across the study
• Offers a data export feature that allows standard and customizable dataset exports in .CSV and .XLS formats at any point during or after the study

AE/SAE Reporting

• Supports timely reporting of Adverse Events (AE) and Serious Adverse Events (SAE) to stakeholders and regulatory bodies
• Includes automatic email notifications triggered by AE/SAE reporting actions to keep users informed

Medical Coding

• Provides a built-in coding interface integrated with the EDC system's real-time data
• Uses standard medical dictionaries including MedDRA and WHO-Drug Global
• Supports coding of verbatim terms to harmonized and standard codes for consistent medical coding across the study

SyMetric's EDC is available through the SAP Store and accessible via the SyMetric Portal. The platform is web-based, supporting remote access for study teams and investigation sites throughout the clinical trial process.