Data Management

Once a study has been analyzed, a data transmittal sheet/case report form is completed. Paper CRFs are copied and the original is returned to the sponsor or CRO. If an electronic CRF is used, the data will be downloaded directly into an Access database. All data is run through a quality control check to ensure all variables are within pre-determined guidelines. Once data has been verified, it will be transferred to the sponsor/CRO electronically. All data fields and parameters can be specified through a data transfer agreement to ensure smooth transmittal of the information. An on-site data manager and on-site statistical support is available for customized data management or analysis.

Customized Reporting

The Cardiovascular Core Labs can provide the sponsor/CRO with progress reports or statistical analysis reports throughout the study. The lab study tracking system can be used to provide progress reports at regular pre-determined intervals or upon request. These progress reports can list every study received by the lab and whether the analysis is complete or pending. As described above, an on-site data manager and on-site statistical support is also available for customized data management or analysis. We work closely with sponsors and

clinical research organizations to perform timely analysis of the data and generation of reports (for example, an interim quality assurance report to determine the yield of a particular parameter on a site-by-site basis can be performed to determine if there is adherence to the imaging protocol). We will also work with your Data Safety and Monitoring Board to produce the interim reports necessary for their proper function. Final reports by a sponsor or CRO can also be reviewed and assistance in preparation for regulatory submission is available.