DZS Previews Enhancements to ClinPlus Report at Pharmasug May 8th-11th
Clinical data and trial management services and solutions organization unveils productivity enhancement tools including a SDTM to ADaM conversion tool and extensive nine domain template library.
New York, NY/Bound Brook, NJ – April 25, 2011 – DZS Software Solutions, a specialty provider of clinical data and trial management software services and solutions, today announced they will unveil the latest enhancements to their ClinPlus Report Software at the annual SAS User Group meeting in May.
Effectively meeting the clinical data study standards set out by the Clinical Data Interchange Standards Consortium (CDISC) specifically with regards to the Study Data Tabulation Module (SDTM) and the Analysis Data Model (ADaM) has been a significant challenge for many pharmaceutical companies, contract research organizations (CROs), biotechs, and medical device manufacturers seeking to expedite clinical trials and meet the strict data formatting requirements of the FDA and other global regulatory agencies. Converting SDTM data to ADaM data and then to submission ready tables while accurately documenting the process can present an even larger challenge.
Providing complete documentation on the creation of study tables and listings that includes the underlying ADaM data sets; a process by which each variable in the ADaM data set is traced back to its original source and cross referenced to the statistical analysis plan is the first hurdle. CDISC specifications indicate that any variables copied or derived from an SDTM domain and converted into an ADaM data set must retain the integrity of the original data in the SDTM domain. A second hurdle is to produce and present in-text tables and data listings in a highly-readable manner with consistent formatting from table to table and study to study.
In response to these customer challenges, DZS Software developed their ClinPlus® ADaM Data Conversion and Reporting Toolkit, an elegant solution for both metadata-driven conversion of SDTM data to ADaM data and the production of metadata-driven flexible safety tables and listings from the ADaM data. The metadata, defined in Microsoft Excel® spreadsheets becomes the ADaM documentation, thereby eliminating any chance that documentation does not correspond to the actual process.
The second step of producing submission ready safety tables and listings uses ClinPlus’s ADaM Report Generator with the newly converted ADaM data as input. Root templates are provided in nine domains including Demographics, Subject Status, Adverse Events, Concomitant Medication, Medical History, ECG, Physical Exams, Vital Signs and Lab data from which many variations of the default report layout may be generated by altering the parameter values in the report metadata. For instance, an Adverse Events table may display PLACEBO as the first column or last column or the same Adverse Event table can display AEs across Treatment Group or across Severity by manipulating the metadata parameters.
"DZS continues to focus on improving clinical trial productivity in all phases of the clinical trial process, by using technologies that leverage the value of trial data and improve the quality of that data to support regulatory approval for new compounds and medical devices. These powerful software tools position our clients to take advantage of breakthrough technology, gain competitive advantage and collapse their drug development lifecycle.” said Doron Steger, CEO, DZS Software Solutions. To speak to a product expert or arrange a personalized demonstration, please contact firstname.lastname@example.org or follow this link to DOWNLOAD A FREE WHITEPAPER ON ADaM CONVERSION, or request specific information or pricing please go to: http://preview.tinyurl.com/3fuyehq