Systems and methods for managing clinical trials
First Claim
1. A method of performing a clinical trial, the clinical trial directed by a sponsor utilizing site monitors to oversee one or more clinical investigators, each investigator having a number of study subjects, the investigator capturing study data from the subjects, the method comprising:
- independently gathering data from study subjects separately from the investigators for review and input into a subject monitoring database; and
observing a quality of the study by analysis of the independently gathered data.
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Accused Products
Abstract
Improved clinical trial methods including the use of subject monitors operating separately from standard clinical trial facilities and/or protocols. The subject monitors may independently or separately contact individual subjects to reinforce trial protocols, and observe compliance levels. Databases may be built and maintained for providing indications of the quality of a clinical trial. Clinical trial materials may be provided via the use of the independently operating subject monitors.
32 Citations
19 Claims
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1. A method of performing a clinical trial, the clinical trial directed by a sponsor utilizing site monitors to oversee one or more clinical investigators, each investigator having a number of study subjects, the investigator capturing study data from the subjects, the method comprising:
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independently gathering data from study subjects separately from the investigators for review and input into a subject monitoring database; and
observing a quality of the study by analysis of the independently gathered data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of performing a clinical trial, the clinical trial directed by a sponsor utilizing a network of clinical investigators, each investigator having a number of study subjects, the investigator distributing study drug to the study subjects and capturing study data from the study subjects, the method comprising:
- independently performing interviews with study subjects separate from the study sites; and
independently delivering study drug to the study subjects separate from the study sites. - View Dependent Claims (13)
- independently performing interviews with study subjects separate from the study sites; and
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14. A method of performing a clinical trial, the method comprising:
- establishing a study subject network at a number of investigator sites using a first collection of personnel;
performing study functions including study drug delivery and study result gathering using a subject monitoring group and sample delivery group for study subjects at a plurality of study sites, the subject monitoring group being separate from the first collection of personnel.
- establishing a study subject network at a number of investigator sites using a first collection of personnel;
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15. A method comprising:
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contacting a number of subjects involved in a current clinical trial to determine whether individual subjects are experiencing the clinical trial in a correct manner and, if not, performing corrective action with respect to the individual subject and recording an intervention related to the individual subject; and
observing whether interventions occurring in the current clinical trial fall within an acceptable range by reference to a database containing information related to interventions in other clinical trials. - View Dependent Claims (16, 17, 18, 19)
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Specification