Hypernet

Through our state-of-the-art Internet technology, Hypernet, we are able to provide web-based clinical trials services to speed up the data handling processes, facilitate project management and save costs.

One of the most advanced web-based solutions for conducting clinical trials, Hypernet offers users a number of advantages:

- Allows real time data collection from multiple sites requiring only minimal technical infrastructure.
- Based on sophisticated CINECA technology with high-level encryption, Hypernet guarantees optimal security.
- Hypernet has been fully validated by an independent company, Pharma Quality Europe, to ensure that it conforms with the FDA 21CFR11 and European regulations regarding Electronic Records and Signatures.

Combining real time data entry with a wide range of on-line features, Hypernet has been proven in a dozen projects involving more than 25,000 patients. For the user the system provides a number of benefits:

• Improved data quality
• Faster data processing
• Reduced query frequency
• Smoother project management
• Reduced costs

Hypernet is a TRUE web-based application

Benefits of a true web-based application:

• Portability; standard browsers on multiple platforms
• Centralization; multiple users get access to a central database
• No Local data to be protect
• Local application always updated
• End-to end source data verification; replaces CRF to database audit
• Easy to use
• HTML forms provide a widely known and easy-to-use interface
• Access 24/7/365; allows patient registration & data review any time
• Cooperative working area; sharing of information

Benefits for the Investigator:

• No data storage at site
• No local software installation and updates
• Interactive remote data entry
• One PC for multiple studies
• Real time overview on study progress
• On line SOPs & other study documents
• Final local archive on a CD ROM

Benefits for the Sponsor:

• Direct access to data limits need for faxing/ phoning or project management information
• Real time overview on study progress
• Immediate notification of Serious Adverse Events and related patient's information

Benefits for the Project Manager:

• Real time information on screening, enrolment, CRF completion, query status, drug accountability, monitoring status
• Real time information on clinical site and project staff activities
• Online clinical data access by Data Safety Monitoring Boards
• Online data availability for easy and timely interim analysis
• Online monitoring reports and tracking on regulatory documents

Main features:

• Automatic enrolment, randomisation, coding and audit trails
• Remote data entry
• Local study and patient management
• Specific local lab units values accepted
• Diagnostic images exchange
• E-queries
• Online documents, protocol, CRF help, newsletters, training, etc
• Documents and material tracking
• Quality Reports

Security:

Protected with IANUS technology Every user’s PC is centrally controlled through an access gate, which cannot be duplicated The Internet is secure through its architecture Data is secured through encryption (up to 128 bit) Pre-defined procedures for securing servers and clients

Regulatory issues:
Hypernet meets the FDA(*) and European regulations and validation process on Electronic Records and Signatures
(*) 21 CFR 11- FDA 1678 Guidance

Competitive advantages:

• Cost-effective tool for multicentre worldwide clinical trials
• Faster study progress
• Higher data quality
• Minimal training of participants
• Minimal equipment at local sites
• Simplifies standard procedures
• Controlled access
• Centralised and up-front quality check
• Customised solutions
• High-level security
• Compliance to regulatory requirements