Secure Data Collection, Storage, & Management

MMI provides long-term, electronic management of medical images and data for your clinical trial. Our validated, 510(k)-cleared data management system provides reliable storage, processing, and tracking of study-related images and data. All data is managed in accordance with good clinical practices and 21 CFR Part 11. We also provide strict safeguards for the protection of intellectual property and patient confidentiality. Our all-digital, state-of-the-art infrastructure allows for maximum efficiency and productivity, while supporting rigorous quality control and compliance.

Features of our data management system include:

• Proprietary clinical database with integrated storage of all trial-related data.
• 510(k) cleared,  21 CFR Part 11 compliant, verified and validated
• Compliant with HIPAA and EU-safe harbor regulations.
• Support for electronic image submission and de-identification.
• Secure, long-term storage with redundant, offsite backup.
• Multi-reader blinding and adjudication.
• Remote, 24x7 access to study images and data.
• 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-Transfer™ is our proprietary image submission system that provides an intuitive interface for image transmittal from the study sites to our facility. Electronic transfers reduce the time, cost, and paperwork needed to submit images compared to courier-based methods. We provide support for all standard file formats including DICOM, JPEG, BMP, TIF and AVI. Images may be uploaded from CDs, fileservers, imaging systems, or PACS archives. The images are electronically de-identified, encrypted, and time-stamped, and a transmittal form is automatically generated. We also provide support for alternative digital transfer mechanisms including DICOM Transfer and FTP as needed.

On-Demand, Remote Image Access

MMI-View™ is our proprietary image display technology that provides remote access to study images. Sponsors, investigators, consultants, and others can enjoy secure, multi-party review of images for pre-enrollment screening, meeting preparations, and AE investigations. This eliminates the manual processes and costs associated with transporting and managing CDs. The software is downloaded via secure internet connection and updates automatically during log-in. Access is controlled via study-specific log-in privileges determined by the sponsor. A helpdesk is available for technical support.

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