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: 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 method for linking records (related to an entity) from separate databases may include extracting a first record from a first database as a first vector, extracting a second record from a second database as a second vector, generating first and second sub-vectors for the first and second vectors, where each sub-vector includes quality features from the respective vector, pre-processing the first and second sub-vectors using domain knowledge, calculating a distance assessment classifier based on the first and second sub-vectors, and determining whether the distance represented by the distance assessment classifier is greater than a threshold. If the distance is greater than the threshold, the records may be linked; if not, the method extracts additional records and repeats after generating first and second sub-vectors until the distance is greater than the threshold. A system for linking records is also disclosed.

Abstract: A system for determining relative operational performance in a clinical trial may include a processor, a data comparator and visualizer, and a graphical user interface. The processor filters received clinical data into multiple metric criteria to generate multiple metric data sets and filters each metric data set into a respective industry data set and a respective candidate data set. The processor then calculates statistical measures for each industry data set and candidate data set and transforms each industry data set and candidate data set based on each data set's respective statistical measures. The data comparator and visualizer compares each transformed candidate data set to the transformed industry data set for the respective metric criterion to determine a candidate percentile for each metric criterion. The graphical user interface displays the candidate percentiles for the metric criteria. A method for determining relative operational performance in a clinical trial is also described.

Abstract: An improved clinical trial patient burden calculating system includes a data analyzer to calculate scores and weights for patient burden components, a plurality of data calculators to calculate a respective plurality of sub patient burden indexes based on the patient burden component scores and weights, and an aggregator to calculate a procedure-level patient burden index based on aggregation of the sub patient burden indexes. An improved method for calculating clinical trial patient burden is also described and claimed.

Abstract: An improved system for determining clinical trial site performance includes a site data filter for separating data corresponding to a clinical trial site into at least one site performance factor category data stream, where each site performance factor category comprises at least one site performance factor and each factor comprises at least one factor choice, a data stream analyzer for analyzing the site performance factor category data stream to determine a factor choice met for each site performance factor and to output a value for the determined factor choice, where the determined factor choice is multiplied by a weighting value, and an aggregator for aggregating the weighted, determined factor choices into a site performance index, where the weighting value is adjusted based on a user's input. An improved method for determining clinical trial site performance is also described and claimed.

Abstract: A method for determining a site performance index includes receiving data from one or more clinical trial sites, associating the clinical trial site data with at least one site performance factor, calculating a weighting value for the site performance factor, and generating the site performance index based on the weighted site performance factor. An apparatus for determining a site performance index is also described and claimed and includes a site data filter, a data stream analyzer, and an aggregator.

Abstract: A method for linking records (related to an entity) from separate databases may include extracting a first record from a first database as a first vector, extracting a second record from a second database as a second vector, generating first and second sub-vectors for the first and second vectors, where each sub-vector includes quality features from the respective vector, pre-processing the first and second sub-vectors using domain knowledge, calculating a distance assessment classifier based on the first and second sub-vectors, and determining whether the distance represented by the distance assessment classifier is greater than a threshold. If the distance is greater than the threshold, the records may be linked; if not, the method extracts additional records and repeats after generating first and second sub-vectors until the distance is greater than the threshold. A system for linking records is also disclosed.

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: 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.