INTEGRATED INTERACTIVE SYSTEMS AND METHODS WITH SINGLE TRANSACTIONAL DATABASE AND REPORTING APPLICATION FOR eCLINICAL TRIALS
First Claim
1. A fully integrated, single transactional online system for end-to-end solution in mining, designing, managing, recording, analyzing and reporting of traditional as well as adaptive clinical trials comprising:
- a single transactional system;
a reporting system;
an application server;
a web server;
an interactive voice response server; and
a communication network, whereinthe application server is configured to perform clinical trial functions, the web server coupled to the application server has a user interface to facilitate access to clinical trial functions over an internet based network, the communication network includes ISP (Internet Service Provider)/PSTN (Public Switched Telephone Network)/GSM, (Global System Mobile), the single transaction database uses multiple channels of communication, the system has a single transactional repository with a pyramidal architecture to take clinical trials from silos to fully integrated ones, the system has a single data login system which provides single data point of information and ensures smooth flow of the information from one component to others, andthe system provides real time update of the clinical trial that includes status of investigational sites, treatment effect, clinical study/program status, finances, clean data and safety data.
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Accused Products
Abstract
The present invention relates to a fully integrated systems and methods to offer end-to-end solution in designing, managing, recording, analyzing, mining and reporting of traditional as well as adaptive clinical trials with single transaction database. Particularly, the present invention relates to a system and method for clinical trial which will help pharmaceuticals/biotech/medical device companies and clinical research organizations (CROs) to manage various activities as per the business flow of a clinical trial, right from protocol design to submission of clinical study reports through their various functionalities/modules. Specifically, the present invention is suitable for adaptive clinical trials where the clinical plans are modified based on the results obtained in the single or multiple interim data analysis. More specifically, the present invention offers a closed loop feedback control of trial parameters and expectations to enhance trial success and addresses safety and efficacy concerns without compromising blinding and statistical validity.
61 Citations
21 Claims
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1. A fully integrated, single transactional online system for end-to-end solution in mining, designing, managing, recording, analyzing and reporting of traditional as well as adaptive clinical trials comprising:
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a single transactional system; a reporting system; an application server; a web server; an interactive voice response server; and a communication network, wherein the application server is configured to perform clinical trial functions, the web server coupled to the application server has a user interface to facilitate access to clinical trial functions over an internet based network, the communication network includes ISP (Internet Service Provider)/PSTN (Public Switched Telephone Network)/GSM, (Global System Mobile), the single transaction database uses multiple channels of communication, the system has a single transactional repository with a pyramidal architecture to take clinical trials from silos to fully integrated ones, the system has a single data login system which provides single data point of information and ensures smooth flow of the information from one component to others, and the system provides real time update of the clinical trial that includes status of investigational sites, treatment effect, clinical study/program status, finances, clean data and safety data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification