ClinPrep Clinical Trials Data Standardization and Reporting

Bracy Analytics original Data Standardization software has made this tedious and time consuming task much simpler for any active or completed Clinical Trial. Simply enter raw clinical data (demographics, adverse events, physical exam, chemistry lab, etc.), in any format and submit it to BAI. Bracy Analytics will process your data through our specialized filtering system, ClinPrep, to create standardized analysis datasets that can be used by programmers and statisticians to analyze the clinical data and meet study goals and endpoints.

BAI accepts raw data exported from virtually any system. Our processes recognize data fields and types and look for particular fields depending on which raw clinical dataset is being processed. The output analysis datasets will contain consistent variable names, labels and variable types for all datasets. Cross-study analysis will be easier to perform and manage because every corresponding analysis dataset has the same variable name and type. We can even standardize datasets from previous trials to enable simplified cross-study analysis with current trials.

Bracy Analytics ClinPrep Clinical Trials Data Validation and Standardization service, provides you with up to 13¹ datasets standardized and ready for Statisticians and Programmers to work with. Those data sets include:

• Randomization Analysis
• Exclusion Analysis
• Inclusion Analysis
• Demographic Analysis
• Medical History Analysis
• Physical Examination
• Study Medication Analysis
• Adverse Event Analysis
• Vital Signs
• Medications Analysis
• Disposition Analysis
• Electrocardiogram Analysis
• Laboratory Analysis

The data in each field is acquired from the input datasets, regardless of their formats, or derived using calculations defined in Bracy Analytics Standard Operating Procedures. Each field is edited to ensure that contents, numeric value range and units of measure are appropriate for the data type being represented. Labels for the datasets are standardized and complete documentation of the standardized dataset format is delivered with the datasets.

In addition to the ClinPrep Data Standardization Service, once datasets have been standardized, BAI can employ a standard model to create typical clinical tables & listings required for almost all Clinical Trials. These include demographic data summary tables (study population, disposition of subjects, summary of demographics, summary of medical history, pre-study & concomitant medications), adverse event tables, laboratory summary tables (chemistry, hematology, urine and coagulation labs for descriptive summary, change from baseline, shift from baseline), and vital sign & ECG summaries; up to 21 reports.

To get an estimate for standardizing data from your trial and producing reports, click here.

¹Data Set production may be limited by the raw data you supply. Only those data sets that can be produced or derived from the data you submit can be provided.