Search Patents - Justia Patents Search (2024)

DESIGN ASISTANCE FOR CLINICAL TRIAL PROTOCOLS

Publication number: 20130226610

Abstract: Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.

Type: Application

Filed: April 29, 2013

Publication date: August 29, 2013

Applicant: MEDIDATA SOLUTIONS, INC.

Inventor: Medidata Solutions, Inc.

System and technique for automated medical history taking

Patent number: 4130881

Abstract: An automated medical history taking system and technique wherein selected branch paths through a questioning repertory are provided in accordance with stated patient complaints and wherein medically related questions are automatically propounded even though not specifically selected for review by a patient.

Type: Grant

Filed: January 28, 1974

Date of Patent: December 19, 1978

Assignee: Searle Medidata, Inc.

Inventors: Herbert A. Haessler, Errol L. Elshtain, Taffy Holland

SYSTEM AND TECHNIQUES FOR REPORTING ADVERSE EFFECTS

Publication number: 20090319299

Abstract: Techniques for collecting and reporting adverse events associated with a patient are disclosed. The techniques include providing a user interface to identify drug and medical conditions associated with the patient using standardized drug and medical terminology. The techniques also include generating and displaying a cumulative narrative of user selections on the interface. The cumulative narrative can be directly transmitted to one or more companies and/or and regulatory agencies.

Type: Application

Filed: June 20, 2008

Publication date: December 24, 2009

Applicant: MEDIDATA SOLUTIONS, INC.

Inventors: Glen Michael De Vries, Barton Lewis Cobert, Jordan Bergtraum

METHOD AND APPARATUS FOR PRODUCING REGULATORY-COMPLIANT SOFTWARE

Publication number: 20140250427

Abstract: A method for producing regulatory-compliant software includes validating a software application and freezing the validated software application in a validation portal, proving-in an infrastructure on which the software application operates, and providing evidence of operational change management for a regulatory agency, which evidence comprises documentation that satisfies the agency's compliance rules. A regulatory-compliant software package is also described.

Type: Application

Filed: March 1, 2013

Publication date: September 4, 2014

Applicant: MEDIDATA SOLUTIONS, INC.

Inventors: Isaac Wong, Anthony Hewer, Johnlouis Petitbon, Glen de Vries

APPARATUS AND METHOD FOR MANAGING SOFTWARE TRANSLATION

Publication number: 20140351798

Abstract: An apparatus for use in developing a software application includes a translation manager for generating and maintaining a table comprising tokens, native language messages, and translated messages, a technical coordinator for verifying that the native language messages comply with at least one of policies, grammar rules, spelling rules, and duplication rules, and a translator for translating the native language messages into the translated messages. A method for managing translation in the development of a software application is also described.

Type: Application

Filed: May 24, 2013

Publication date: November 27, 2014

Applicant: Medidata Solutions, Inc.

Inventor: Connor Ross

Apparatus and method for managing software translation

Patent number: 9292271

Abstract: An apparatus for use in developing a software application includes a translation manager for generating and maintaining a table comprising tokens, native language messages, and translated messages, a technical communicator for verifying that the native language messages comply with at least one of policies, grammar rules, spelling rules, and duplication rules, and a translator for translating the native language messages into the translated messages. A method for managing translation in the development of a software application is also described.

Type: Grant

Filed: May 24, 2013

Date of Patent: March 22, 2016

Assignee: Medidata Solutions, Inc.

Inventor: Connor Ross

METHOD AND APPARATUS FOR DETERMINING COMPLEXITY OF A CLINICAL TRIAL

Publication number: 20150178244

Abstract: A method for determining net complexity of a clinical trial includes determining procedures to be performed during the clinical trial, determining which of the procedures may be routinely performed on clinical trial subjects suffering from the disease that the drug under test is designed to treat, determining the net procedures to be performed for the clinical trial itself, and calculating a complexity score for the net procedures. An apparatus for determining net complexity of a clinical trial is also described and claimed.

Type: Application

Filed: December 20, 2013

Publication date: June 25, 2015

Applicant: Medidata Solutions, Inc.

Inventors: Lori Shields, Joshua Hartman

Method and apparatus for producing regulatory-compliant software

Patent number: 9280450

Abstract: A method for producing regulatory-compliant software includes validating a software application and freezing the validated software application in a validation portal, proving-in an infrastructure on which the software application operates, and providing evidence of operational change management for a regulatory agency, which evidence comprises documentation that satisfies the agency's compliance rules. A regulatory-compliant software package is also described.

Type: Grant

Filed: March 1, 2013

Date of Patent: March 8, 2016

Assignee: Medidata Solutions, Inc.

Inventors: Isaac Wong, Anthony Hewer, Johnlouis Petitbon, Glen de Vries

Controlling access to a software application

Patent number: 8875230

Abstract: A system for controlling access to a software application includes a policy machine template generator and a policy machine generator. The policy machine template generator may generate a policy machine template based on roles and permissions. The policy machine generator is coupled to the policy machine template generator and may generate a policy machine based on users and objects. The combination of the policy machine template and the policy machine is also claimed, as is a method for controlling access to a software application.

Type: Grant

Filed: December 19, 2013

Date of Patent: October 28, 2014

Assignee: Medidata Solutions, Inc.

Inventors: Aaron Weiner, Matthew Szenher

Electrophysiological diagnostic catheter especially for obtaining of endomyocardial biopsy of heart tissue

Patent number: 10117644

Abstract: The electrophysiological diagnostic catheter obtains an endomyocardial biopsy of heart tissues. The catheter includes a manipulation handgrip, main channel, distal ring and diagnostic rings connected with electrical connections. There is a centrally located, open internal channel, wherein inlet/outlet of internal channel is located in the distal ring, or is guided and monitored using a system for 3D electroanatomical mapping.

Type: Grant

Filed: March 12, 2015

Date of Patent: November 6, 2018

Assignee: MEDIDATA SP. Z O.O.

Inventors: Sebastian Stec, Sanjeev Choudhary, Janusz Sledz

Controlling access to a software application

Patent number: 9467472

Abstract: A method for controlling access to a software application includes generating a policy machine template based on at least one role and at least one permission for an operator, generating a policy machine based on the operator and at least one object associated with the operator, and maintaining at least one logical link between the policy machine template and the policy machine. The policy machine is an access control framework permitting directed acyclic graph relationships between objects, and the policy machine controls access to the software application.

Type: Grant

Filed: October 27, 2014

Date of Patent: October 11, 2016

Assignee: Medidata Solutions, Inc.

Inventors: Aaron Weiner, Matthew Szenher

SYSTEM AND METHOD FOR MANAGING CLINICAL TREATMENT DISPENSATION

Publication number: 20150112695

Abstract: A system for managing clinical treatment dispensation includes a rules engine and a treatment assignment subsystem. The rules engine is capable of receiving at least two treatment parameters from at least one treatment module and uses the treatment parameters to compute a set of treatment combinations. The treatment assignment subsystem uses the treatment combinations set to generate treatment dispensation information useful for treating a patient. A method for generating a clinical treatment dispensation design is also described.

Type: Application

Filed: October 18, 2013

Publication date: April 23, 2015

Applicant: Medidata Solutions, Inc.

Inventors: Jonathan Lebowitsch, Christine Matakovich, Benjamin Young, Ian Harrington, Christopher Herbst

Method and apparatus for determining complexity of a clinical trial

Patent number: 10892041

Abstract: A method for determining net complexity of a clinical trial includes determining procedures to be performed during the clinical trial, determining which of the procedures may be routinely performed on clinical trial subjects suffering from the disease that the drug under test is designed to treat, determining the net procedures to be performed for the clinical trial itself, and calculating a complexity score for the net procedures. An apparatus for determining net complexity of a clinical trial is also described and claimed.

Type: Grant

Filed: December 20, 2013

Date of Patent: January 12, 2021

Assignee: Medidata Solutions, Inc.

Inventors: Lori Shields, Joshua Hartman

SYSTEM AND METHOD FOR OBTAINING AND UTILIZING AUDITS FROM DISPARATE SOURCES

Publication number: 20150106116

Abstract: Disparate (heterogeneous) clinical data recording devices are assimilated into a unified clinical system that is able to function regardless of the disparate data protocols of the recording devices. The unified system is realized in some embodiments by cascading a consistent set of audits generated by the recording devices through downstream clinical components, which audits provide a permanent and indelible record. The cascaded audits may also serve as a means of instruction between the disparate components of a unified clinical system.

Type: Application

Filed: October 14, 2013

Publication date: April 16, 2015

Applicant: Medidata Solutions, Inc.

Inventors: Glen de Vries, Isaac Wong, Michelle Marlborough

Cryoapplicator for minimally invasive surgical cardiac ablation

Patent number: 10893898

Abstract: The cryoapplicator for minimally invasive surgical cardiac ablation includes a fastening part, an insulation part and an effector tip. A pin is connected with the fastening part on one end, and with the effector tip on the second end. The effector tip is bent by 60° to 90° angle in the side view in relation to pin longitudinal axis, and by 5° to 60° angle in the top view. A thermal insulation cover is located on the pin with the possibility to slide along the longitudinal axis.

Type: Grant

Filed: December 18, 2015

Date of Patent: January 19, 2021

Assignee: MEDIDATA SP. ZO.O

Inventors: Piotr Suwalski, Sebastian Stec, Sanjeev Choudhary

METHOD AND APPARATUS FOR GENERATING A CLINICAL TRIAL BUDGET

Publication number: 20150178873

Abstract: A method for generating a clinical trial budget includes determining a plurality of procedures to be performed during a clinical trial, calculating the likelihood of reimbursem*nt by a third party for each of the procedures, calculating for each of the procedures the expected reimbursem*nt amount, calculating an expected net cost for each of the procedures based on the cost of each procedure and the expected reimbursem*nt amount for each procedure, and summing up the expected net costs of the procedures to determine the clinical trial budget. An apparatus for generating a clinical trial budget is also described and claimed.

Type: Application

Filed: December 20, 2013

Publication date: June 25, 2015

Applicant: Medidata Solutions, Inc.

Inventors: Lori Shields, Joshua Hartman, Theresa Brophy, Sondra Pepe

Method and system for maintaining data in a substantiated state

Patent number: 8949998

Abstract: A method for maintaining data in a substantiated state includes executing one or more services on the data message at a first node, annotating the message header with the services executed at the first node, transmitting the data message over a data network, and receiving the annotated data message at a second node. The annotation corresponds to the services executed at the first node, and the annotated data is extractable from the header for the execution of services at the second node. A system for maintaining data in a substantiated state is also described.

Type: Grant

Filed: July 1, 2013

Date of Patent: February 3, 2015

Assignee: Medidata Solutions, Inc.

Inventors: Isaac Wong, Johnlouis Petitbon, Benjamin Young, Matthew Szenher, Andrew Newbigging

System and method for predicting subject enrollment

Patent number: 11494680

Abstract: A system for predicting subject enrollment for a study includes a time-to-first-enrollment (TTFE) model and a first-enrollment-to-last-enrollment (FELE) model for each site in the study. The TTFE model includes a Gaussian distribution with a generalized linear mixed effects model solved with maximum likelihood point estimation or with Bayesian regression, and the FELE model includes a negative binomial distribution with a generalized linear mixed effects model solved with maximum likelihood point estimation or with Bayesian regression estimation.

Type: Grant

Filed: May 15, 2018

Date of Patent: November 8, 2022

Assignee: MEDIDATA SOLUTIONS, INC.

Inventors: Hrishikesh Karvir, Fanyi Zhang, Jingshu Liu, Michael Elashoff, Christopher Bound

Display screen with a transitional graphical user interface

Patent number: D787526

Type: Grant

Filed: August 6, 2015

Date of Patent: May 23, 2017

Assignee: Medidata Solutions, Inc.

Inventors: David Lee, Joshua Hartman, John Savage, Richard Kwock, Michael Elashoff, Pramod Somashaker

Display screen with a transitional graphical user interface

Patent number: D822688

Type: Grant

Filed: May 11, 2017

Date of Patent: July 10, 2018

Assignee: Medidata Solutions, Inc.

Inventors: David Lee, Joshua Hartman, John Savage, Richard Kwock, Michael Elashoff, Pramod Somashekar