EDC

Sofpromed's Electronic Data Capture (EDC) system is a web-based software tool designed for collecting, cleaning, and exporting clinical trial data. It is intended for biotechnology, pharmaceutical, and medical device companies conducting phase I through phase IV clinical trials across a wide range of therapeutic areas.

The EDC system is used in clinical trials worldwide, covering therapeutic areas including oncology, hematology, cardiovascular, metabolic, central nervous system (CNS), dermatology, infectious diseases, respiratory diseases, and pain, among others.

Core System Characteristics

• Ease of use: Clear design with an intuitive interface intended for straightforward data entry and navigation.
• Speed: Supports quick data entry and efficient navigation through trial records.
• Security: Includes access control and data encryption to protect trial data.
• Accessibility: Fully web-based with no software installation required, accessible across multiple devices, browsers, and operating systems.
• Reliability: Daily data backups are performed to maintain data integrity and continuity of service.
• Built-in tools: Includes monitoring, data management, and reporting functionality within the platform.

Compliance and Regulatory Standards

• Meets HIPAA requirements for data privacy.
• Compliant with Good Clinical Practice (GCP) guidelines.
• Meets 21 CFR Part 11 requirements for electronic records and electronic signatures.

Pricing Model

• Billed on a monthly flat-rate basis, providing a predictable cost structure for trial sponsors and operators.

Sofpromed offers the EDC system as part of a broader suite of clinical research services, including data management, biostatistics, regulatory affairs, and full-service CRO capabilities. A free demo and custom pricing quotes are available directly from the company.