Sponsored White Papers, Webcasts, and Downloads
Additional Resources
- The Electronic Project: Effectively Using Metadata Throughout the Project Life Cycle
- The rapid, reliable, and cost-effective production of FDA deliverables is the Holy Grail of pharmaceutical companies and Contract Research Organizations CROs. Difficult to achieve in a "Calm" environment, they become even more problematic as statisticians, programmers, and project managers edge closer to the maelstrom that is the submission date. The...
- Tags: Metadata, SAS Institute, Federal Government, Development Tools, Government, Software Development, Software/Web Development
- White papers 2007-05-14
- Data Management in Analyzing Clinic Trial Data - Metadata Application
- Efficiently handling Clinical Trial Data based on the Clinical Data Interchange Standards Consortium CDISC standard, the regulatory rules from U.S. Food and Drug Administration FDA and electronic data submission requirements is very important for Drug Development. Effectively managing Clinical Trial data can vastly increase work efficiency and reduce the probability...
- Tags: FDA, Clinical Trial, SAS Institute, Data Management, Federal Government, Healthcare, Government
- White papers 2004-04-14
- Implementing CDISC Submission Data Standards
- Now that the SDTM has become the submission data standard, pharmaceutical and biotech companies are facing the challenge of implementing these standards in combination with their internal operational, and reporting standards. This webinar will focus on how and where to implement the Study Data Tabulation Model SDTM and how analysis...
- Tags: Consortium, Webinar, Standards, Quality, Business Operations
- Webcasts
- CDASH - Building Global Consensus to Define CRF Standards
- The CDASH Clinical Data Acquisitions Standards Harmonization project, initiated by ACRO and led by CDISC, focuses on the FDA Critical Path Opportunity #45, and seeks to develop a set of 'Content standards' (element name, definition, metadata) for a core set of global data collection fields that will support clinical research...
- Tags: SAS Institute, Standards, Quality, Federal Government, Business Operations, Government
- Webcasts
- The CDISC Business Case for Industry Data Standards
- This webcast presents a summary of the findings from early and ongoing implementations of the clinical data interchange standards. Based upon work in other industries, Gartner has reported that automating processes and using data interchange standards can produce significant benefits in process efficiencies. To help address the change management issues...
- Tags: Industry, SAS Institute, Standards, Change Management, Quality, Strategy, Tools & Techniques, Management, Business Operations
- Webcasts
- The Biomedical Research Integrated Domain Group (BRIDG) Model
- The Biomedical Research Integrated Domain Group BRIDG model is a means of bridging various standards, different organizations and the domain of clinical research with that of healthcare. It is a domain analysis model of protocol-driven research. This webcast will provide an overview of the BRIDG, including purpose, history, status and...
- Tags: Domain, SAS Institute, Biomedical, Standards, Quality, Business Operations
- Webcasts
- Why Clinical Development Teams Should Care About Data Standards - Part I: An Introduction to the CDISC Operational Data Model (ODM)
- Standards have the potential to increase the value of clinical trial information by allowing ready exchange among partners and integration for broader and better reviews; in fact, standards can drive innovation. The CDISC Operational Data Model ODM was designed to provide a vendor-neutral, platform-independent means of exchanging data among clinical...
- Tags: Team, Clinical Trial, Standards, Healthcare
- Webcasts
- The Business Case for CDISC Data Standards: Affirmation and Implementation
- This webcast will take information gathered from major pharma companies, Contract Research Organizations CROs and the FDA, and discusses how an organization can leverage data standards to gain competitive advantage, automate processes and lower the cost of drug development.
- Tags: Business Case, SAS Institute, Standards, Federal Government, Government
- Webcasts
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