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silicon.com > White Papers > Data Management > Data Infrastructure
Supporting CDISC Standards in Base SAS Using the SAS Clinical Standards Toolkit
The use of regulatory standards aimed at clinical research data and metadata has become more commonplace over recent yea Read more
May 29, 2009
silicon.com > White Papers > Data Management > Data Infrastructure
The Second CDISC Pilot Project: A Metastandard for Integrating Databases
The first CDISC SDTM/ADaM pilot project created a test submission of one study to the FDA using CDISC data and metadata Read more
May 29, 2009
silicon.com > White Papers > Data Management > Data Tools
Implementing CDISC When You Already Have Standards: A Case Study
How one chooses to implement CDISC will be based on current company standards and their robustness, the amount of contro Read more
May 29, 2009
silicon.com > White Papers > Data Management > Data Tools
Mapping CDISC Metadata Attributes: Using Data _Null_ and Proc Datasets in SAS
In the pharmaceutical environment, the CDISC Study Data Tabulation Model (SDTM) provides the framework for how clinical Read more
May 30, 2009
silicon.com > White Papers > Enterprise Applications > Workflow Management
Epicor Software Case Study: Synovis Interventional Solutions
Synovis Interventional Solutions is a diversified medical products company that develops devices for the interventional Read more
May 30, 2009
silicon.com > White Papers > Data Management > Data Infrastructure
Data Collection (Case Report Form) Standards: What You Need to Know About CDASH
A Gartner business case for standards has identified the benefit of applying data standards in the start-up stage of cli Read more
Jun 2, 2009
silicon.com > White Papers > Data Management > Data Infrastructure
Results and Lessons From the CDISC SDTM/ADaM Pilot Project
The CDISC SDTM/ADaM Pilot Project was conducted as a collaborative pilot project with FDA and Industry. The objective of Read more
Jun 2, 2009
silicon.com > White Papers > Software and Web Development > Internet and Web
Food and Drug Administration and the Google Search Appliance
The FDA is a scientific, regulatory and public health agency that works to ensure the safety, efficacy, and security of Read more
Jun 22, 2009
silicon.com > White Papers > Security > Security Administration
Cost-Effective Compliance With FDA Regulations for Your SAP Applications
Pharmaceutical companies operate in one of the most highly-regulated industries in the world. As most companies sell to Read more
Jul 18, 2009
silicon.com > White Papers > Enterprise Applications > Enterprise Planning
Accounting and Manufacturing Solution Eases Compliance for Antimicrobial Manufacturer
PURE Bioscience develops technology-based bioscience products for numerous global health challenges. The fast-growing co Read more
Jul 25, 2009
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