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Wayne, PA, United States, 2007/03/19 - Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, today announced the release of Data JumpStart.
New offering provides Octagon’s data standardization expertise incorporated into one comprehensive package.
Chairman and CEO, Jim Walker of Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, today announced the release of Data JumpStart, a new offering designed to assist companies in the efficient deployment of new industry data standards across their organization and outsourcing partners. This new offering combines Octagon’s collective breadth of knowledge and experience in the preparation of SDTM and CDISC compliant submission ready data components and consulting services.
Octagon’s CDISC SDTM compatible Data JumpStart offering is a collection of documents, libraries and templates that facilitate institutionalization of data management standards and provides everything a company will need to deploy data standards across an organization and to outsourcing partners. The package represents over 300 hours of expert development time by Octagon’s CDISC knowledgeable data management professionals.
“The idea of Data JumpStart, came about from our work with various clients. We recognized that frequently many organizations experience a lack of resources and knowledge in regard to data management, particularly the emerging data standards”, stated Dan Crawford, director, Clinical Data Strategies. “The goal of Data JumpStart is to assist organizations to push standardization upstream as far as possible. Once standardized, the next logical step is integration and analysis of safety and efficacy data across studies, which enables companies to make "go/no go" decisions earlier in the drug development process.”
Data JumpStart includes:
· Case Report Form Library – Collection of twelve standard case report forms that leverage CDISC SDTM Nomenclature
· Annotated Case Report Forms with SDTM variable names (delivered in Adobe FrameMaker or PDF format)
· Variable Names Library - details variable names that can be used within in each dataset, categorized by dataset
· CDISC SDTM compatible laboratory specifications for central lab vendor
· Standard Query Library – Approximately 50 standardized queries to provide consistent quality data; reduces rework and re-querying of issues. This collection supports paper, fax-based and electronic data capture (EDC) studies
· Comprehensive Data Management Plan template – 60 pages of expert guidance aids in the development and rapid deployment of a data management plan
“Data JumpStart continues our commitment to develop solutions that immediately address industry’s critical pain points by accelerating standardization of electronic documents and data”, added Jim Walker. “Data JumpStart complements our existing Clinical Data Legacy Conversion Services, TurningPoint Assessments and Roadmap Implementation offerings for Data standardization and conversion. We have already seen a great deal of interest in this offering from industry.”
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Amersham, UK.