PAPERS CONTINUED...


Professional Development & Training What makes a strong programming team? Challenges Facing the Programmer in Observational Research Introduction of Pharmaco-economics for non-health economists Programming for Early and Late Phase – really that different? How do we support ongoing development of our programmers? Collaboration versus conflict: building successful working relationships Managing Telecommuters and Global Virtual Teams Critical Path Learning – How to Develop Top Level SAS® Programmers Regulatory FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards


Preparing an eSubmission based on multiple trials some of which are ongoing – challenges for statistical programming Modular Programming - Some Lessons Learned and Benefits Gained Understanding NDA/BLA Clinical Data Submission The growing pains of Validation – have we past the point of puberty? Software Demonstration Sopanam- Tracking SAS® QC process the efficient way! CYA with JMP - reloaded The Evolution of Coding Technology - Demonstration SAS® Data Management Studio Using meta-data and SAS® macros to simplify and automate reporting activities in clinical trials “Overnight” Conversion to SDTM Graphical Patient Profiles driven by CDISC standards Managing standards: Impact analysis in a metadata driven standards library Study Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata Access Control Execution System (ACES) Architect - A Platform for Design and Analysis Software for Clinical Trials Statistics & Pharmacokinetics An Animated Guide: An Introduction to Latent Class Clustering in SAS® Bayesian hypothesis testing for proportions Different Methods of Calculating Body Sway Area Text Analysis of Pubmed articles for Research Topics Embedding equivalence t-test results in Bland Altman Plots visualising rater reliability Use of early longitudinal viral load as a surrogate to the virologic endpoint in Hepatitis C Estimation of relative potency in a 4-point parallel line assay Precision of the PK metrics used in BE/BA studies Technical Solutions Genericity - New Metadata Concepts Applied to SAS® Macro Programming Implementing ADaM Using the SAS® Clinical Standards Toolkit Implementation of CDISC standards supported by a globally distributed mapping process: Case Study Alternative Approaches to Creating Disposition Flow Diagrams Using Dynamic Lists in SAS® Stored Processes for Genetic Toxicity Historical Control Data Scalable Vector Graphics in SAS® 9.2

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