Secure, Electronic Management of Images and Data
MMI employs a proprietary electronic data management system validated in accordance with 21 CFR Part 11 (Electronic Signatures and Audit Trails). All data are managed with the utmost attention to privacy and confidentiality. Firewalls, role-based logins, and electronic security keys control access to study information and data. All data are managed at a secure, Tier 3 colocation facility with redundant storage, fire suppression, and environmental controls.
Our data management system is designed to aid sponsors of clinical studies in storing and maintaining clinical study data. Features of our data management system include:
- Proprietary, SQL database with integrated storage of all trial-related data.
- Validated, 21 CFR Part 11-compliant software platform.
- Compliance with HIPAA and EU privacy shield regulations.
- Support for electronic image submission and de-identification.
- Secure, long-term storage at a Tier 3 data center with redundant, offsite backup.
- Multi-reader blinding and adjudication with software-mediated error avoidance.
- On-demand access to study images and data through remote viewing software.
- Paperless data capture, storage, and reporting.
- Electronic discrepancy management functions.
- Multi-layer security with restricted access to networks, software, and data.
Secure, Digital Image Transfer
MMI has partnered with Medidata to bring you Medidata Medical Imaging™ – a secure, web-based image transfer platform enabling clinical study sites to upload images and avoid courier shipping. The platform features cutting-edge tools for high-volume file transfers with flexible workflows and full regulatory compliance. Images may be uploaded from CDs, fileservers, imaging systems, or PACS archives in a wide variety of file formats. The images are electronically de-identified, encrypted, and time-stamped, and a transmittal form is automatically generated. We also provide support for alternative transfer mechanisms when needed.
On-Demand, Remote Image Access
We offer proprietary remote image access technology (MMI-View™) that permits sponsors and clinical study sites to view images for pre-enrollment screening, DSMB meetings, and AE investigations. Software-based access to the study database eliminates the manual processes and costs associated with transporting and managing CDs. The software is downloadable via secure connection and updates automatically. Access is controlled through study-specific log-in privileges. A helpdesk is available for technical support. MMI-View™is designed for research use only.