Abstract: A system for producing a clinical trial software application includes a processor, comprising a validation service and an audit service, and a platform, configured to prove-in an infrastructure on which the software application operates. The software application operating on the infrastructure is the same as the software application previously validated in a validation portal. The proving-in of the infrastructure comprises receiving infrastructure requirements from a software application supplier, building the software application supplier's instances, logging an installation report to the validation portal, and comparing the log to the frozen, validated software in the validation portal. The validation service is configured to validate the software application, freeze the validated software application in the validation portal, and generate documentation that satisfies compliance rules for the clinical trial software application.

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.

Abstract: Devices and methods are disclosed for use and processing of patient geolocation data in order to objectively determine a patient's territory as an artificially created digital biomarker while maintaining locational privacy. The objective determination of a patient's territory, defined as the area traversed in a specific time interval, can be used as a measurement of quality of life, as well as socio-economic contribution and benefit. Devices and methods are also disclosed for creating an artificial Overall Territory Activity Digital Biomarker based on Patient Activity Factors in addition to the Patient Territory Digital Biomarker, and which Overall Territory Activity Digital Biomarker also maintains locational data privacy. Furthermore, devices and methods are disclosed for capturing and transmitting digital biospecimens, the transformed geolocation data used to determine the Patient Territory Digital Biomarker.

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.

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.

Abstract: A method for ensuring integrity of data includes receiving data from a clinical source, assembling the data into a first data stream, generating a first hash number by applying a hashing algorithm to the first data stream, transmitting the first data stream to a data provider, and transmitting the first hash number to a data checker. The data provider provides to the data checker a second data stream and the data checker generates a second hash number based on the second data stream and compares the first hash number to the second hash number. A system for ensuring integrity of data is also described and claimed.

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.

Abstract: The present invention provides an imaging service method and system by which medical images stored in the DICOM standard in a central medical imaging repository may be seamlessly and securely accessed, and operated on, by electronic data capture (EDC) or eClinical data systems. The interoperability between web-based Medical Imaging Repositories and eClinical systems provided by the present invention may increase data quality and visibility to clinical workflow involving medical imaging, decrease delays in accessing images and their clinical measurements, and improve the functionality of DICOM-based MIR systems by providing measurement-based versions.

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 reimbursement by a third party for each of the procedures, calculating for each of the procedures the expected reimbursement amount, calculating an expected net cost for each of the procedures based on the cost of each procedure and the expected reimbursement 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.

Abstract: A method and system for generating a master clinical database from disparate sources, including public databases, private databases, and data from users, correlating the received data, determining a degree of confidence in and requesting and seeking confirmation of any data matched from the correlated data. The invention may identify key time points and users from whom to seek and receive confirmation of correlated data. The invention may be utilized to create a cross-trial, cross-sponsor, clinical master database that maintains appropriate user, subject and data confidentiality and privacy and which may be utilized to facilitate study design collaboration.

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.

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.

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.

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.

Abstract: A method for generating a unified database includes receiving a structured set of data, where each set is made up of records having fields, aggregating values within a first field of the records, automatically applying a set of rules to the first field values to determine correlations among the first field values, calculating a confidence level regarding a label for the first field, providing the label to the first field, storing the first field values in the first field in the unified database, and receiving more information to increase the confidence level. A system for generating a clinical database and a method for using the database are also described.

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.

Abstract: System and method of managing a clinical trial in accordance with a protocol are provided. In accordance therewith, a workflow associated with the protocol is accessed from a first data structure. The workflow includes a plurality of workflow tasks to be performed in connection with treatment of a plurality of patients according to the protocol. Instruction is provided to clinical personnel to perform one or more workflow tasks according to the workflow in connection with a visit of a patient out of a plurality of visits. Progress of the patient through the workflow is recorded to a second data structure as performance or non-performance of the one or more workflow tasks in connection with the visit on a per-visit basis.

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.