Secure, Electronic Management of Images and Data
We employ a validated, 21 CFR Part 11-compliant, proprietary data management platform purpose-built for clinical trials. Firewalls, physical security measures, and role-based logins control access to study information and data. All data are managed at a secure colocation facility with redundant storage, fire suppression, and environmental controls.
Our data management system offers the following features and benefits:
- Integrated storage of all study images and data.
- Paperless data capture, storage, and reporting.
- Electronic signatures and audit trails per 21 CFR Part 11.
- Compliance with HIPAA and GDPR requirements.
- Electronic image submission and de-identification.
- Multi-reader blinding and adjudication.
- Electronic discrepancy management and reporting.
- Long-term data storage with redundant offsite backup.
- Remote image access, viewing, and download.
- Multi-layer security with role-based access control.
Secure Image Transfer
MMI has partnered with Medidata to provide integrated support for Rave Imaging, a secure image transfer platform enabling sites to upload images to our servers. Images are de-identified, encrypted, and time-stamped during transfer and can be viewed remotely on our systems after receipt. For Rave EDC users, the images are also accessible through a single sign-on solution in Rave. As needed, we support other image transfer solutions per sponsor preferences and study requirements.
Remote Image Access
Our proprietary MMI-View™ technology permits sponsors and partners to view images on demand, such as for pre-enrollment screening, DSMB meetings, and AE investigations. The software is downloadable via secure connection and updates automatically. Access to images and data is controlled through study-specific login privileges. A help desk is available for technical support. (MMI-View™ is for investigational use only and is not intended for patient diagnosis or management.)