Method for conducting a clinical study
First Claim
1. A method for conducting a clinical study comprising the steps of:
- (a) operating a medical facility over time in a plurality of conventional interactions respectively with a plurality of patients and, for each of said interactions, producing data;
(b) storing said data as stored data;
. (c) in a clinical study conducted by an evaluation entity for a medical product that departs from said conventional interaction, identifying a need for specific data relevant to said clinical study;
(d) making said stored data available to said entity; and
(e) said entity comparing said stored data to said need and extracting data from said stored data to fulfill said need.
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Accused Products
Abstract
In a method for conducting a clinical study, such as a clinical trial for governmental approval of a medical product, a medical facility is operated in a conventional manner over time in a number of interactions respectively with a number of patients and, for each interaction, data are produced and stored. For conducting a clinical study for a medical product that departs from the conventional interaction, an entity conducting the study identifies a need for specific data relevant to the clinical study. The stored data are made available to the entity, and the entity, or a representative of the entity, compares the stored data to the need and extracts data from the stored data to fulfill the need.
16 Citations
11 Claims
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1. A method for conducting a clinical study comprising the steps of:
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(a) operating a medical facility over time in a plurality of conventional interactions respectively with a plurality of patients and, for each of said interactions, producing data;
(b) storing said data as stored data;
.(c) in a clinical study conducted by an evaluation entity for a medical product that departs from said conventional interaction, identifying a need for specific data relevant to said clinical study;
(d) making said stored data available to said entity; and
(e) said entity comparing said stored data to said need and extracting data from said stored data to fulfill said need. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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Specification