LIST OF FEATURES

INTERNET MANAGEMENT / Features

• Transparency and traceability - All the process of CRF can be verified and traced by the client at his profile.
• Fast start - Project will start fast and easy, thanks to the remote site initiation
• High exactness of the information/data - Elevated level of data consistency and integrity.
• Minimum terms between primary steps in clinical data management and statistics - PMS stage permits making the final convenient format faster by automated system for Data Clarification and exporting of the collected data.

INTERNET MANAGEMENT complies with 21 CFR, Part 11 Guidelines (is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)):

• Secure Individual Authorization
• Limitation of inactive session
• Logging the wide range of users actions and activities
• Data validation prior saving
• Tracking CRF changes and reasons for CRF editions

Management and trials systems

Advantages:

• Fast project's startup
• Reducing of assets required for project management and follow-up
• Comfortable use of remote monitoring module
• Secureness of captured data (on-case on-site monitoring, online monitoring)
• Auto Inquiries decrease monitoring costs
• Confidentiality of data
• Data integrity and traceability