Waban Software Releases Waban CDR-SCE v 2.5.1.1
Waban’s Clinical Data Repository (CDR), Statistical Computing Environment (SCE), and Submission Metadata Manager (SMM), provide a controlled and integrated 21 CFR Part 11 and CDISC compliant metadata-driven repository and environment for managing complex clinical data handling, biostatistics, and statistical programming processes.
Cambridge, MA and Berlin, Germany (March 23, 2009) - Waban Software, a leading industry provider of software solutions (Data Capture, Integration, Reporting, Analysis & Delivery) for Pharmaceutical and Biotech companies, today announced the availability of Waban CDR-SCE version 2.5.1.1 at the 21st Annual DIA Euro Meeting in Berlin, Germany.
This latest upgrade will introduce new clinical data repository, analysis management and reporting features that will continue to optimize customer’s data analysis and reporting processes in the critical e-clinical data flow. Some of the key features of this upgrade are:
- Study and Clinical Metadata Management.
- Define.xml generation for CDISC SDTM and ADaM Standards
- Metadata-driven Clinical Data Integration and Processing
- Metadata-driven Checks for Standards Conformance
- User-defined Schemas and Standards
- Additional Support for third-party tools
- Security and Auditing-related Enhancements.
Waban Clinical Data Repository (Waban CDR) and Waban Statistical Computing Environment (Waban SCE) provide a secure 21 CFR Part 11 compliant, version-controlled data repository for storing and managing clinical trial data (both data and metadata) along with preparation of clinical data for submission to the regulatory agencies. Waban CDR-SCE allows Data Managers, Bio-Statisticians, and Statistical Programmers to retrieve, explore, browse, query, analyze and report clinical trial data. In addition, other related documents such as CRFs are also stored in Waban CDR-SCE. The Waban CDR repository allows direct access to data and metadata. Contained in this solution is software designed for the speedy analysis and reporting of clinical data for submission to regulatory agencies. The Waban SCE enables end-to-end traceability of data files, statistical analysis source code, outputs, and reports with version-control and audit trials. The Waban system has connectors for data originating from a variety of sources (EDC, CDM, CTMS etc.) and to several analysis tools such as SAS®, SPLUS®, R, iReview®/JReview® and Spotfire®.
"This latest release will help our customers move one step closer to an integrated repository for their eClinical data flow needs. The many new features extend support for the CDISC standards, improve the metadata, and data management and reporting functions", stated Dr. Himanshu Oberoi, President, Waban Software.
About Waban Software
Waban Software provides life sciences information management solutions that enable pharmaceutical and biotechnology companies to easily capture, integrate, access, manage, and analyze life sciences and clinical trial data on a single platform. Waban's solutions help companies to significantly streamline the management of data from drug discovery and development processes, enabling more rapid analysis and submission to regulatory authorities.
Waban Software is a privately-held company headquartered in Cambridge, MA., USA . For more information, visit us at: www.wabansoftware.com
Press Contact:
Pratap Malik, Ph.D.
Vice President
Waban Software, Inc.
617-868-8911 ext. 201
pmalik@wabansoftware.com
|
