Hypernet

The Hypernet system has been developed with the objective to be stable, secure and scalable and to facilitate the  role of all the personnel involved in a clinical trial, anywhere in the world, on any computer, and  through any browser.

Hypernet main functionalities:

• Investigator-oriented interface

• Record, tracking and real time reporting of subject-related data according to client and protocol requirements

• Controlled access by means of user ID and password

• Data coding

• Audit trails

• Remote data entry on paper-like, friendly forms

• Specific local laboratory units values accepted

• Upload, review and exchange of diagnostic images

• Possible upload into the system of external files,  from third parties

• E-queries

• High security for the clinical trial data: daily, monthly and yearly back ups

• Support of standards for data interchangeability : CDISC compliant

• Integration with SAS through a specific Oracle-SAS on demand download module

• Environmental precautions such as temperature control, fire/gas/ detection, physical access

• Availability of disaster recovery plan

Benefits for the Investigator:

• Easy to be consumed even for people without any experience in working with EDC

• Friendly layout

• Easy navigation from page to page or among different forms

• Data entry free from logical errors

• Unique repository for all subjects data (Oracle Database)

• Centralized query process

• Easy access to other HyperSuite® modules (Hyper ePRO, Hyper IWRDS, Hyper eSAE, Hyper File)

Benefits for the Sponsor:

• Real time monitoring of trial progress

• Increased efficiency and effectiveness for CRAs

• Real time safety information

• Decreased time period from last patient last visit to database lock

• Improved  data quality

• Real time monitoring of individual and aggregate performance metrics

• Immediate extraction and analysis of data when needed