US 12,248,389 B1
Monitoring technology usage and data quality in decentralized pharmaceutical trials
Praduman Jain, Fairfax, VA (US); Josh Schilling, Salem, OR (US); Dave Klein, Oakton, VA (US); and Mark James Begale, Chicago, IL (US)
Assigned to VigNet Incorporated, Fairfax, VA (US)
Filed by Vignet Incorporated, Fairfax, VA (US)
Filed on Mar. 5, 2021, as Appl. No. 17/193,717.
Application 17/193,717 is a continuation of application No. 16/877,162, filed on May 18, 2020, granted, now 11,461,216.
This patent is subject to a terminal disclaimer.
Int. Cl. G06F 11/34 (2006.01); A61B 5/00 (2006.01); G06N 20/00 (2019.01)
CPC G06F 11/3466 (2013.01) [A61B 5/7275 (2013.01); G06F 11/3438 (2013.01); G06N 20/00 (2019.01)] 23 Claims
OG exemplary drawing
 
1. A method performed by one or more computers, the method comprising:
receiving, by the one or more computers, data collected for participants in a clinical trial using one or more technology items, the data being received over a communication network from remote devices associated with the participants, wherein the clinical trial involves use of a pharmaceutical by the participants and the clinical trial has a protocol that specifies methods of collecting data from the participants using the remote devices during the clinical trial;
evaluating, by the one or more computers, usage of the one or more technology items by the participants in the clinical trial at multiple times during the clinical trial to determine whether the one or more technology items are used by the participants according to the methods specified in the protocol or whether the collected data provides a level of data quality needed for the clinical trial;
determining, by the one or more computers, based on the evaluation of the usage of the one or more technology items that one or more requirements of the protocol for the clinical trial are not satisfied, including determining that a particular type of data is not collected according to a predetermined set of criteria from at least a subset of the participants;
in response to determining that one or more requirements of the protocol are not satisfied:
providing, by the one or more computers, a notification to one or more devices of a researcher associated with the clinical trial, the notification indicating that the one or more requirements for the clinical trial are not satisfied;
identifying, by the one or more computers, multiple technology items as candidates to obtain the particular type of data from participants in the subset; and
selecting, by the one or more computers, an alternative technology item for the participants in the subset; and
sending, by the one or more computers, software or configuration data over the communication network to the remote devices associated with the participants in the subset, wherein the software or configuration data is configured to adjust operation of the remote devices to initiate collection of the particular type of data using the selected alternative technology item.