CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

Why Should You Attend:

This course will focus on all of the key resources and tips required by SAS statistical programmers in the pharmaceutical industry. Project management using SAS Enterprise Guide, as well as analysis, reporting and validation of clinical data such as lab data will be reviewed. CDISC and 21CFR Part 11 regulatory requirements will also be emphasized.

Attendees will be able to download and apply relevant SAS examples and utilities. In addition, SAS statistical programmers can access useful tips on each of the five analytical SAS procedures e-guides as well as debugging tips. Both managers and technical professionals will benefit from this course. To better manage access to SAS Savvy online resources, attendees will be able to download twenty SAS Savvy mind maps.

Learning Objectives:

• Better manage projects with practical tools to understand data content and quality
• Apply validation methods to reduce time to validate clinical summary tables
• Apply advanced SAS programming techniques to standardize and automate the validation process
• Leverage online resources to use real-world SAS examples and best practices

Areas Covered in the Webinar:

1. Project Management and Tools
1. Applying Project Management and General Utilities: Flow Chart, Program Index, Table of Contents
2. CDISC Strategies: Variable Definition Tables, DEFINE.XML, CDISC Express
3. Data Quality Checks: SAS Macros, Clinical Data Acceptance Testing
4. Decode SAS Macro Programs
2. Analysis, Reporting and Validation
1. Applying Clinical Data Reporting and ODS Style: SAS Macros, ODS Template
2. Processing Lab Data: Baseline, Standard Units and Visit Windows
3. Useful Data Validation QC/QA/Data Quality Techniques: Validation SOP, Scan SAS Logs and Proc Compare
3. SAS Savvy Mind Maps and Resources
1. Tips on Top Five Analytical SAS Procedures: Proc Freq, Means, Report, SQL, and Tabulate
2. Accessing SAS Topics: Data Management, Advanced SAS Programming, and Analytical Analysis
3. Applying Effective SAS Debugging Techniques
4. Utilizing the Benefits of SAS Enterprise Guide
5. Searching Over 100 Common SAS Programming FAQ

Who Will Benefit:

This course is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this unique course. In addition, this course is ideal for IT groups supporting FDA submissions. Effective and practical solutions to address real-world issues will be provided. This course is recommended for:

• SAS Statistical Programmers
• Quality Assurance Specialists
• SAS Statistical Managers
• Medical Writers
• Statisticians
• Regulatory Affairs Associates
• Clinical Data Managers
• Directors, Statistical Programming
• CRO Professionals
• Health Care Professionals
• Research University Specialists

Instructor Profile:

Sunil Gupta is an international speaker, best-selling SAS author, and a global corporate trainer. He is the principal SAS/CDISC consultant at Gupta Programming since 1994. Most recently, he taught both of his CDISC online classes with the University of California at San Diego and SAS Institute India. Mr. Gupta will start to teach the new Sharpening Your SAS Skills online class for UCLA Extension in 2016. In 2011, he launched his unique SAS resource blog, SASSavvy.com, for smarter SAS searches. Currently, SAS Savvy’s membership consists mostly of SAS programmers, university students and pharmaceutical corporate accounts.

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