Hypersuite

Hypersuite is a web-based Clinical Data Management solution. The birth of Hypersuite, goes back to end of the 1990s when Cineca laid the basis of a commercial, technological and scientific adventure. Recognized as one of the largest European supercomputing centers, Cineca was able to draw on its long experience with universities and other academic research centers.

At that time only a few people in both Pierrel Research Italy and Cineca were fully convinced that the web was the future of multicentre clinical trials and found the courage to give life to their vision and bring Hypernet to market.

Fortunately these people were right, and now Hypersuite is an established reality, used all around the world in many clinical studies. In fact Hypernet, the e-CRF module, has been used with more than 250,000 patients involving 6,500 clinical sites for about 200 projects in over 43 countries.

During the years that have passed since the birth of Hypernet, our vision of Electronic Clinical Data Management has grown stronger, benefiting from continuous advances in technology and cultural changes in the pharmaceutical industry.

Hypernet 2.0 is a pure web-based system allowing real time data collection from multiple sites requiring only minimal technical infrastructure and no additional software installation.

Hypernet has been fully validated for the second time on 2007, to ensure that it conforms to the FDA 21 CFR Part 11 and European regulations regarding Electronic Records and Signatures.

Hypernet’s main functionalities

• Investigator oriented interface
• Automated enrolment, randomization, coding and audit trails
• Remote data entry on paper-like, friendly forms
• Centralized double data entry of paper CRFs
• Local study and patient management
• Specific local lab units values accepted
• Diagnostic images exchange
• Possible support for third parties external files upload in the system (for integration with patient devices)
• E-queries
• Online documents, protocol, CRF help, newsletters, training, etc
• Documents and material tracking
• Real-time study performance reports

Hypernet security

• Data transaction is secured through encryption (up to 128 bit)
• Hypernet servers hosted at CINECA (the largest Italian supercomputing centre)

Controlled access to the computer room

Access to room limited to authorized people, by means of user ID and password.

Computer room: temperature control, fire precautions, gas detection, physical access, etc.

All security requirements are fully satisfied by CINECA procedures.

Computer system Disaster Recovery Plan

Disaster & Recovery Plan is available. Documentation of two test recoveries of the Pierrel Research Italy system and of the oracle database successfully performed in June 2006 is available at CINECA for audit purpose.

Data back-up procedures

Back up procedures are directly managed by CINECA. Data are daily back-upped, until the 8th version are kept.

Weekly dump unto magnetic tape and yearly dump until optical support are also performed.

Moreover the data are daily transferred via Virtual Private Network (VPN) to a back up site (50 kilometers away from the CINECA main facilities).

Web-based eCTMF / eISF document management and archiving tool. Supports original electronic documents and scanned ones. Each document always printable. Real time, on-line reports on missing documents, per center and per CTMF/ISF sections, and on time delays from document issued dates and document filing dates. Final copy of study files on CD.

Phone and web-based Multimedia Messenger System / Broadcast phone and web-based multimedia messenger system / Contact all or sub-groups of participants to a clinical study in a fast, immediate, on-click , easy, secure and traceable way . Supports email, SMS, fax, Text-To-Speech, digitalized human voice (the machine reads messages written by the sender). Schedule and tracking of all communications.

Our Integrated Web-based Randomization and Drug Supply system is used for centralized study randomization and global supply management . Each Investigator by the mean of User-ID and password will get access to IWRDS system and will have to answer questions on study selection criteria. If the patient properly fulfills the selection criteria the system will immediately assign the randomized pack.

Therefore our IWRDS prevents the inclusion of patients violating the protocol requirements.

This translates into better study performance, Higher data quality and ultimately lower study costs.

Based on the randomization rate at each site and on the drug kit expiring dates the system generates an automated “order notification” for the re-supply to the site.

System features

• Self-serve
• Easy to use
• Secure
• 24/7/365 availability
• Multi-Center Clinical Trials
• Custom algorithms
• Stratifications
• Reduction of the drug overproduction costs
• Optimal study drug distribution
• Substantial reductions in drug supply wastage and distribution costs
• Assured randomization continuity by timely re-supply alert
• Expiry date management
• e-code unblinding
• Automated inventory control
• Management of complex study drug dispensing schedule
• Real time of patient progress, treatment assignments, supply location and status

The introduction of this new module allows the notification of a SAE from the site. Instead of using the traditional SAE Fax Form, the Investigators, via the e-study web-site, may fill in the SAE related information into the eSAE Report Form. By electronically signing and submitting it, an immediate notification via mail is sent to all the appropriate study team members. The SAE Reports, both initials and follow-up, may be queried via the Hypernet e-query system and might be printed or downloaded.

In double-blind study if, following a SAE, the Investigator needs to break the drug code, this functionalities allows the request to unblind the study code. The unblinding will be released only when a SAE has been reported. Immediate notification of the code breaking is sent to all the appropriate study personnel.

Interactive phone-based patient diary system, which uses human digital voices to speak to the patient ("Text-To-Speech" technology) / Dramatic increase in diary quality and compliance because the system automatically calls the patient, according to the specific diary time schedule / Fully customizable to each study / Patient’s PIN code identification and answers by using the phone keyboard / Mobile phones supported/ Automated alert to investigator of severe symptoms reported by patient/ Patient’s reported data automatically entered into patient’s eCRF/ voice mail box for additional patient’s message to investigator/Printing and signature by patient of the reported ePRO data.