SAS Drug Development: Intelligent Research Management
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1 SAS Drug Development: Intelligent Research Management Andrew Fagan R&D Director Pharmaceutical Software Development SAS
2 Shaping the Intelligence Layer 2
3 Drug Development Issues ! Average cost: $802 million.! Time to market: years.! Withdrawals from the market.! Diminishing pipelines.! Decreasing periods of exclusivity. 3
4 Key Drug Development Challenges! Corporate Executives:! Streamline clinical trial process to reduce time-to-market and cost.! Identify potential drug problems/failures earlier in the research process.! Clinical Executives:! Improve access to research program information.! Empower medical staff to explore research data directly. 4
5 Key Drug Development Challenges! Biostatistics Directors:! Reduce time necessary to validate and document work; allow more time to transform data and perform statistical analyses.! Identify a more efficient way to work that reduces timeline challenges throughout the research process.! IT Managers:! Streamline documentation process to meet federal regulations.! Reduce IT overhead on repeated installations and associated documentation for updates, bug fixes and new software releases. 5
6 Value of Intelligence to Drug Development Process 6
7 Provide Centralized Access! New clinical trial data.! Existing clinical trial data.! Third-party data.! Documents and images. 7
8 Determine Clinical Trial Results! Reporting wizard for ICH-based reports.! Integrated summaries of safety and efficacy.! Ad hoc analyses. 8
9 Explore Research Data! New marketing claims.! Potential product line extensions.! Critical drug safety issues. 9
10 Enable Regulatory Compliance! Electronic signatures.! Audit trails.! Versioning.! Security. 10
11 The Role of Organizational Intelligence: Business Process Flow Bring all associated research information together in one location. Assess safety and efficacy on a per trial basis, or across trials. Support all activities within a compliance-enabling system. 11 Find hidden opportunities within the body of knowledge you ve already built.
12 SAS Drug Development Benefits! Centralizes access to data, documents and files.! Includes sophisticated data exploration tools.! Generates ICH-based statistical summaries.! Manages SAS programming activities with versioning, audit trails and documentation support.! Strongly enables 21 CFR Part 11 compliance.! ASP-based or traditional implementation options. 12
13 SAS Drug Development Delivers! Smarter, evidence-based decisions.! Early identification of critical safety issues.! Discovery of hidden opportunities.! Clinical program management optimization for reduced time-to-market.! Centralized access to clinical research data with user empowerment.! Streamlined regulatory compliance.! Leveraged data and technology investments. 13
14 SAS Drug Development! Combines leading technology, process and industry expertise to enable your team to efficiently move your research programs to the next phase.! Provides the intelligence needed to:! Empower your organization to transform raw data into usable intelligence about your clinical research programs.! Furnish decision makers with reliable information that they can act upon with confidence.! Share the information throughout your organization to help maximize profitability, minimize risk and achieve competitive advantage. 14
15 SAS Drug Development System Overview 15
16 The SAS Difference! The de facto standard for analysis and data transfer in the pharmaceutical industry.! Designed to support 21 CFR Part 11 compliance.! Maximizes the intelligence derived from volumes of data.! Information is put where it s needed most in the hands of the user.! 25 years of expertise in building responsive, intelligent solutions. 16
17 If you need more information! Contact us at the Industry Knowledge Center - until 10:30 Thursday! Brochures! Copies of the paper! Visit our web site:! 17
18 18 Copyright 2002, SAS Institute Inc. All rights reserved.
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