FORM-2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL SPECIFICATION
(See section 10; rule 13)


SYSTEM FOR CLINICAL DATA MANAGEMENT

TATA CONSULTANCY SERVICES LTD.,
an Indian Company
of Nirmal Building, 9th Floor, Nariman Point, Mumbai 400 021,
Maharashtra, India
THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION


FIELD OF THE INVENTION
This invention relates to the field of automation and clinical data management systems.
BACKGROUND OF THE INVENTION AND PRIOR ART
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These are achieved by conducting clinical trials and collecting safety and efficacy data from these trials for the new drugs, devices and the like.
Clinical Data Management Systems (CDMS) are used in clinical research to manage the data of a clinical trial. The clinical trial data for the particular patient and the drug, devices and the like is collected at the investigator site and stored in the CDMS. At the end of the clinical trial the dataset in the CDMS is analyzed and sent to the regulatory authorities for approval.
The costs for conducting these trails is increasing, due to the complex nature of the tests, increased duration of the tests and the complexity of combining the trial data for various patients and drugs from various locations. There is therefore a need for a system that can reduce the timeline of the trials as well as help in reducing costs and make the trail data available in a user friendly format for simplifying the analysis. Moreover, there is a need for standardizing the metrics for analyzing efficiency and cost of CDM activities so that they could roll up to the larger objectives of pharmaceutical
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companies. Also, there is no way of seeing an integrated view of a clinical study as it progresses across multiple processes.
The present invention envisages a clinical data management system adapted to generate reports across different functional areas, thus achieving a cost effective integrated approach and delivery excellence in CRO (Clinical Research Outsourcing) services. Particularly, reports are generated on clinical data management metrics.
OBJECTS OF THE INVENTION
An object of the invention is to provide collaboration between diverse functioning clinical data management systems.
Another object of the invention is to automate metrics, scorecards, planning and tracking of clinical studies.
Still another object of the present invention is to simplify routine status reporting and dashboard generation for various parameters like On Time Delivery, Productivity and Quality.
Yet another object of the present invention is to derive intelligence about CDM processes
Sill another object of the present invention is to optimize the cost of CDM services through bird's eye view of cost and efficiency data.
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Yet another object of the present invention is to connect disparate metrics into the larger scorecard of Pharmaceutical and CRO companies
SUMMARY OF THE INVENTION
According to the present invention, there is a provided a system which typically consists of data models and deployment approaches for implementing CDM systems. Its key value add is in the ability of being customizable to CDM processes in different pharmaceutical companies irrespective of the variance in metrics set by these companies. This system is flexible, dimensionally modeled and provides valuable insight into processes that effect key decision parameters in bringing drugs to market.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWING
The invention will now be described in relation to the accompanying
drawing in which,
Figure 1 illustrates typical technical architecture of the CDM system.
DESCRIPTION OF THE INVENTION
The invention will now be described with reference to the accompanying drawing which does not limit the scope and ambit of the invention. The description provided is purely by way of example and illustration.
The CDM system as seen in Figure 1 of the accompanying drawings typically includes:
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ASTeR: A database designated as ASTeR, in accordance with the present invention, is a structure that can be deployed on a relational database. ASTeR analyzes the data and facilitates generation of reports and dashboards.
In accordance with the present invention, different databases including time tracking systems, general ledger (GL) and accounting, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC) and the like, can connect with ASTeR by means of extract, transform and load tool (ETL). Also, data can be extracted from ASTeR by means of a front end reporting tool.
ETL: ETL, in accordance with the present invention, extracts data from various databases including time tracking systems, GL and accounting, CTMS, EDC and the like, transform it and load the data in a specific format in ASTeR.
Users: Users typically include the investigators, clinical data managers, regulatory managers, CROs, CXO's, site co-ordinates and the like. Users can use the system for reviewing the data in a report or dashboard form based on metrics including time taken for performing the clinical trials, overview of the data received from a specific trial, costs incurred, test results and the like.
While considerable emphasis has been placed herein on the particular features of this invention, it will be appreciated that various modifications can be made, and that many changes can be made in the preferred embodiments without departing from the principles of the invention. These
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and other modifications in the nature of the invention or the preferred embodiments will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.
Dated this 6th day of February, 2009.

MOHAN DEWAN
Of R. K. DEWAN & CO.
APPLICANTS' PATENT ATTORNEY
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