Management of Clinical Data, Analysis & Reporting

The e-clinical pathway today requires a continuous stream of clinical trial data flow from data capture to submission. The dependency relationship between the various versions of data, programs, reports and the audit trail information is critical to the management of this complex data analysis processes.

Waban Software has helped pharmaceutical and biotech companies in providing strategic consulting services and software products for the data management of clinical data, analysis and reporting. To this end, Waban Software has developed and implemented its products Waban CDR and Waban SCE. The end users may be data managers, clinical researchers, biostatisticians, statistical programmers or medical reviewers. The implemented systems have been used for the traditional development and reporting of tables, listings and graphs (TLGs), for modeling and simulations or for preclinical, Phase I or Phase IV.

Waban CDR and Waban SCE allows the creation of study templates to formalize and automate the analysis process and has features like version control (check in and check out) of datasets, documents and scripts. All objects are versioned and the job control component ensures that standard reports such as the creation of a binder can be automated and tracked. Further, complete traceability from the source datasets through the analysis programs to the output is maintained by managing inputs and outputs. Waban CDR and Waban SCE also supports data from leading clinical data management systems (Oracle® Clinical, Clintrial® etc.) and the CDISC formats (SDTM and ADaM).