Clinical trials must comply with the regulatory requirements of FDA’s 21 CFR part 11 guideline, which establishes rules for trustworthy electronic records and signatures. Image processing software needs to offer appropriate mechanisms to duly meet these requirements in the context of standard operating procedures. PMOD has integrated into its ATL version all constituents necessary for compliant image processing workflows. The main ATL features beyond the standard PMOD functionality include: tight access control, strong data protection, detailed change tracking, sophisticated logging of all activities, and flexible report generation.
PMOD’s ATL version was initially developed in close collaboration with a major Clinical Research Organization (CRO) specialized for molecular imaging. Meanwhile, several other CROs have integrated it into their 21 CFR part 11 compliant environment and routinely employ it for analyzing trial images. Productivity of the ATL version has been proven in enterprise setups with up to 15 data analysts, simultaneously working with more than 35 trial databases.
“PMOD provides state-of-the-art solutions in processing and analysis of medical image data. Its built-in audit trail is a must-have to comply with regulatory requirements in clinical trials. We really appreciate the responsiveness of PMOD’s support team.”
- Centralized Administration
- Configurable Database Access
- Flexible License Management
- Audit Log of All Processing Steps of Base And Fusion Modules
- Macro Reprodcution of Image History Buffers
- Audit Log Filtering
- Image History Access
- Reporting And Printing