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Clinical Trials Software

Mobile Clinical Trials Fast, Securely & Private

Digitally Extending Clinical Trial Data for Anytime, Anywhere Access

PDA cortex introduces a groundbreaking centralized Clinical Trials Information Management Platform.

Clinical Trial investigators and co-ordinators can electronically create and extend in minutes their own forms for the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata onto any handheld computing device or PC via wireless or any other connectivity option.

Efficiencies of A Digital Clinical Trial System

The PDA cortex Clinical Trials Information Management Platform* digitizes information flow and centralizes management and access to all data across offices, departments and third parties.

Centralized Mobile Data Flow Management

PDA cortex Clinical Trials Information Management Platform enables the fast, easy centralized deployment and management of clinical trials data and metadata applications and paper-based systems seamlessly onto handheld devices:

xManager is a centralized management console providing control over what data goes out to individual users and what access is permitted to the software systems.

Build-Your-Own: allows users to quickly create rich dynamic documents that are seamlessly sent in one step to any mobile device and PC. The XML data that is collected from the created form is instantaneously delivered to any computing system.

Researchers can electronically create and extend in minutes their research projects and surveys onto any handheld computing device or PC via wireless or any other connectivity option.

  • 24/7 access to information for remote & mobile users
  • Convert paper-based systems into electronic forms in minutes
  • Reduces paper usage and its costs
  • Seamlessly receive and send data to any database
  • Use it with any analytical software tool
  • One day installation times
  • Auto-tracking of data input errors & authentication of data
  • Costly data re-entry errors from paper to PC are eradicated
  • Collaboration is enhanced and made easier and more efficient through centralized computerized management system
  • Physicians, Researchers & Subjects electronically enter data at the point-of-incident
  • Data and Study updates are seamlessly synchronized to and from remote PC's and mobile devices of users
  • Add validations for field values and data
  • Collaboration is enhanced and made easier through a centralized information management console that controls the data flow, access and permissions of all users
  • Manage multiple studies simultaneously

Ensuring Security & Privacy of Your Mobile Network

xClient offers three levels of functionality:

1.) One option that provides the greatest security and privacy of organizations systems being accessed in the field makes the handheld device into a mobile dumb terminal. The handheld's security vulnerable operating system (e.g. WindowsCE, PocketPC, Palm, RIM, etc.) is removed and xClient installed. This dedicated purpose mode ensures no virus, worms and Trojans can be introduced into the network through the handheld.

2.) A form that is created with Build-Your-Own ('BYO') is accessed remotely by a mobile user who will only see forms available to them. The XML parser sends a string of data of that form to the device formatting it automatically to the handheld being used by the user. The XML data that is entered is seamlessly migrated back to the corporate server leaving no data on the device that may be stolen or lost through the handheld.

3.) Store-and-Forward: Data is allowed to be stored on the device. When the end-user connects to the network a bi-directional synchronization occurs.

Anonymous Database Storage:

This highly secure & private database configuration is an innovative and patent pending dual process database running parallel with bi-directional synchronization. The databases are running independently but parallel. The researcher or patient/subject enters the data that is entered for research directly. The other is clinical that contains patient information and is accessed only by the physician or researcher (i.e. physician/researcher). The security mechanism prevents a patient from extracting data from the research database or that of the clinical database. The research database is structured so that if it were hacked the data is maintained in such a way that a hacker cannot identify a user to any data. An unauthorized user is not able to see any patient names for there are none. All access to the data comes through the clinical side by the physician/researcher that through a variety of security means will be able to match the data from the research dB to the clinical dB record. A participating physician can only access data in the research db of their specific patient.

Key Leading Edge Points of the Secure & Private Database Technology:

  • Two Separate but parallel running databases: One for Clinical patient Information and Research Database (Anonymously stored research data) that are separate but run parallel with bi-directionally synchronized.
  • Generic Database Framework: This allows the data entered through the dynamic form creation tool Build-Your-Own to be stored and retrieved information based on forms created using BYO.

 

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