ClinPlus®Report 4.0, Dramatically Improves Programmer Productivity for Production of CDISC ADaM Data and Safety Tables & Listings
The latest release of ClinPlus® Report, the company’s powerful authoring software for creating high-quality statistical tables and listings from all types of clinical data. Version 4.0 offers an optional ADaM Data Conversion and Reporting Toolkit with a 50+ Template Library that when used together, generates CDISC ADaM compliant safety tables and listings for ten data domains, while providing all supporting documentation in a validated, standardized way.
Bound Brook, NJ, April 07, 2009 --(PR.com)-- · An Excel metadata-driven process, pre-configured to convert CDISC SDTM data to ADaM structures
· Excel metadata spreadsheets double as ADaM documentation, complete with SAP cross-references.
· Extensive template library for generation of CDISC ADaM compliant safety tables and listings for ten data domains with all supporting documentation in a validated, standardized way.
DZS Software announced today the latest release of ClinPlus® Report, the company’s powerful authoring software for creating high-quality statistical tables and listings from all types of clinical data. Version 4.0 offers an optional ADaM Data Conversion and Reporting Toolkit with a 50+ Template Library that when used together, generates CDISC ADaM compliant safety tables and listings for ten data domains, while providing all supporting documentation in a validated, standardized way.
This release is particularly timely and critical, as the pharmaceutical industries strives to effectively meet 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). Converting SDTM data to ADaM data, and then to submission-ready tables, listings, and graphs, as well as accurately documenting the process, can be daunting. However, adhering to CDISC standards can facilitate efficient data integration in addition to access and review.
The latest release of ClinPlus® Report provides complete documentation for the creation of tables and listings and the underlying ADaM data sets, the process by which each variable in the ADaM is traced back to its original source. This is key to meeting CDISC specifications on retaining the integrity of the original data in the SDTM domain. Additionally, the software produces and presents in-text tables and data listings in a highly readable manner with consistent formatting from table to table and study to study.
Key to the value of this software is that your ADaM data and safety tables/listings may be produced from SDTM data with no additional programming, saving significant time and expense when preparing final Clinical Study Reports. This proprietary conversion process can be easily configured to convert data structures other than SDTM by simply modifying the metadata. The templates may also be tailored and supplemented with additional safety and efficacy templates, as needed, for each sponsor.
Other features in the new release are the ability to have Profile Listings display data across any number of domains, by patient. This feature allows you to easily run a random sample listing of patients to support the data management QC process after study lock.
According to Bob Borysko, VP of Programming and Development at DZS Software Solutions, “This latest release underscores our commitment to helping the life science industry meet the challenges of both regulatory and standards-setting bodies as efficiently and effectively as possible.” Added Mr. Borysko “Our goal is to offer robust solutions to help our clients leverage these standards in order to expedite clinical trials.”
The DZS/ClinPlus Services Group also supports many client needs with a variety of outsourcing services that provide basic and advanced training, produce additional tables and listings, or customize existing templates.
For more information, or a comprehensive system demonstration please contact: salesandmarketing@clinplus.com.
About DZS Software Solutions, Inc.
DZS Software Solutions, Inc. (www.clinplus.com) is a privately held company founded in 1996 providing clinical trials software for clinical data management and analysis to the biotech and pharmaceutical industry worldwide. Over 50 clients globally presently use ClinPlus® software for data collection and capture, data cleansing, coding, analysis, clinical trial management and reporting. When the software is coupled with DZS services and training, many ClinPlus clients have dramatically improved productivity and maximized the value of clinical research investments and gained a competitive advantage to get medicines and products to market faster.
The ClinPlus® Software Solutions Suite for Clinical Trials provides premium tools required by pharmaceutical companies, contract research organizations (CROs), biotechs, and medical device manufacturers to expedite clinical trials and meet the strict data formatting requirements of the FDA and other global regulatory agencies.
The ClinPlus® Software Solutions Suite’s unmatched cost-of-entry, scalability, flexible delivery options and exceptional training and support have gained DZS a reputation for delivering exacting quality and helping clients achieve early visibility to reliable clinical data.
DZS software engineers possess decades of statistical analysis, clinical data management, and ADE/Drug coding and table/list/report building experience. This real-world experience is incorporated into every ClinPlus® system design and is evident in the reliability and enhanced features found in every system.
Contact:
Keith W. Ward
Director of Global Marketing
DZS Software Solutions, Inc.
1661 Route 22 West
Bound Brook, NJ 08805-1258
Office: (732) 764-6969 Ext: 129
Fax: (732) 764-6755
kward@clinplus.com
www.clinplus.com
###
· Excel metadata spreadsheets double as ADaM documentation, complete with SAP cross-references.
· Extensive template library for generation of CDISC ADaM compliant safety tables and listings for ten data domains with all supporting documentation in a validated, standardized way.
DZS Software announced today the latest release of ClinPlus® Report, the company’s powerful authoring software for creating high-quality statistical tables and listings from all types of clinical data. Version 4.0 offers an optional ADaM Data Conversion and Reporting Toolkit with a 50+ Template Library that when used together, generates CDISC ADaM compliant safety tables and listings for ten data domains, while providing all supporting documentation in a validated, standardized way.
This release is particularly timely and critical, as the pharmaceutical industries strives to effectively meet 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). Converting SDTM data to ADaM data, and then to submission-ready tables, listings, and graphs, as well as accurately documenting the process, can be daunting. However, adhering to CDISC standards can facilitate efficient data integration in addition to access and review.
The latest release of ClinPlus® Report provides complete documentation for the creation of tables and listings and the underlying ADaM data sets, the process by which each variable in the ADaM is traced back to its original source. This is key to meeting CDISC specifications on retaining the integrity of the original data in the SDTM domain. Additionally, the software produces and presents in-text tables and data listings in a highly readable manner with consistent formatting from table to table and study to study.
Key to the value of this software is that your ADaM data and safety tables/listings may be produced from SDTM data with no additional programming, saving significant time and expense when preparing final Clinical Study Reports. This proprietary conversion process can be easily configured to convert data structures other than SDTM by simply modifying the metadata. The templates may also be tailored and supplemented with additional safety and efficacy templates, as needed, for each sponsor.
Other features in the new release are the ability to have Profile Listings display data across any number of domains, by patient. This feature allows you to easily run a random sample listing of patients to support the data management QC process after study lock.
According to Bob Borysko, VP of Programming and Development at DZS Software Solutions, “This latest release underscores our commitment to helping the life science industry meet the challenges of both regulatory and standards-setting bodies as efficiently and effectively as possible.” Added Mr. Borysko “Our goal is to offer robust solutions to help our clients leverage these standards in order to expedite clinical trials.”
The DZS/ClinPlus Services Group also supports many client needs with a variety of outsourcing services that provide basic and advanced training, produce additional tables and listings, or customize existing templates.
For more information, or a comprehensive system demonstration please contact: salesandmarketing@clinplus.com.
About DZS Software Solutions, Inc.
DZS Software Solutions, Inc. (www.clinplus.com) is a privately held company founded in 1996 providing clinical trials software for clinical data management and analysis to the biotech and pharmaceutical industry worldwide. Over 50 clients globally presently use ClinPlus® software for data collection and capture, data cleansing, coding, analysis, clinical trial management and reporting. When the software is coupled with DZS services and training, many ClinPlus clients have dramatically improved productivity and maximized the value of clinical research investments and gained a competitive advantage to get medicines and products to market faster.
The ClinPlus® Software Solutions Suite for Clinical Trials provides premium tools required by pharmaceutical companies, contract research organizations (CROs), biotechs, and medical device manufacturers to expedite clinical trials and meet the strict data formatting requirements of the FDA and other global regulatory agencies.
The ClinPlus® Software Solutions Suite’s unmatched cost-of-entry, scalability, flexible delivery options and exceptional training and support have gained DZS a reputation for delivering exacting quality and helping clients achieve early visibility to reliable clinical data.
DZS software engineers possess decades of statistical analysis, clinical data management, and ADE/Drug coding and table/list/report building experience. This real-world experience is incorporated into every ClinPlus® system design and is evident in the reliability and enhanced features found in every system.
Contact:
Keith W. Ward
Director of Global Marketing
DZS Software Solutions, Inc.
1661 Route 22 West
Bound Brook, NJ 08805-1258
Office: (732) 764-6969 Ext: 129
Fax: (732) 764-6755
kward@clinplus.com
www.clinplus.com
###
Contact
DZS Software Solutions
Keith Ward
732-764-6969
www.clinplus.com
Bob Borysko, VP Programming and Development
x128
Keith Ward
732-764-6969
www.clinplus.com
Bob Borysko, VP Programming and Development
x128
Contact
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