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"getting FDA at conference was a great addition"


Conference 2007

PhUSE 2007 was October 8th through October 10th. This third PhUSE conference was held at the Corinthia Hotel in Lisbon and was chaired by Dirk Spruck (Accovion), who has made a significant contribution to the organisation of PhUSE since its conception in 2004. The conference built on the hugely successful conferences that were held in the picturesque city of Heidelberg, Germany in 2005 and the vibrant city of Dublin, Ireland in 2006.

The three day conference ran four parallel streams of presentations. There was also the opportunity to browse the demonstration and exhibition areas and interact with CROs, solution providers and software vendors as they promoted their products.

2007 Conference room

The conference committee were delighted that this year's keynote address was given by Dr. Armando Oliva, M.D., Deputy Director for Bioinformatics in FDA's Office of Critical Path Programs.  Dr. Oliva addressed the development, implementation and adoption of data standards at the FDA, with particular emphasis on activities related to CDISC, HL-7 and the Janus Data Warehouse. 

As has become traditional at PhUSE the main conference social event was scheduled for the Monday night. This year the event was sponsored by Quintiles and was held at Kais restaurant in Lisbon.

As in previous years the very well attended manned poster session was held on Tuesday evening, with wine and cheese provided courtesy of i3 statprobe. 

2007 Papers

Best paper winners are highlighted in bold text.

Applications and Software Development

AD01: Coding Standards for the Un-Standardizable
Richard Pugh & John James, Mango Solutions (Size: 87 Kb)

AD02: Debugging Standard Macros
Anthony Cooper, GlaxoSmithKline (Size: 52 Kb)

AD03: LSLV to Final CSR Tables in 24 hours - Dream or Reality?
Stinder Fowler, Pfizer Global Research and Development (Size: 480 Kb)

AD04: MAKS: A validated SAS Macro Library for data in SDTM structure
Rolf Meinert, Katrin Bhalla-Muller, Jessica Wisniewski, Daniel Wachtlin; KKS-Mainz (Size: 28 Kb)

AD05: Web-enabling the Pharmaceutical sector
Raymond Ebben & Jules van der Zalm, OCS Consulting (Size: 868 Kb)

AD06: Liberate, a SAS reporting system
David Royle, Huntingdon Life Sciences Ltd (Size: 2366 Kb)

AD07: Method Validation in a PAT Environment using a SAS EG Addin
Robert Huisden, OCS Consulting (Size: 375 Kb)

AD08: Designing a Global SAS9 Architecture for analysis and reporting
Andrew York, Covance CAPS, & Gregory S. Nelson, ThotWave Technologies (Size: 252 Kb)

Coder's Corner

CC01: SAS Indexes: Benefits, Limits and Applications
Carole Beaugendre, Quintiles (Size: 40 Kb)

CC02: Merging by formats
James McGiffen, GlaxoSmithKline (Size: 35 Kb)

CC03: Web techniques for SAS ODS output and more
Jules van der Zalm, OCS Consulting (Size: 57 Kb)

CC04: Simple %str(ER)ROR checking in macros
Magnus Mengelbier, Limelogic (Size: 111 Kb)

CC06: Improving maintenance and performance of SQL queries
Bas van Bakel & Rick Pagie, OCS Consulting (Size: 102 Kb)

CC07: The Pros and Cons of PROC DOCUMENT
Philip R Holland, Holland Numerics Limited (Size: 91 Kb)

Coding solutions

CS01: SASMAX - Maximise potential of reusing SAS code
Beate Hientzsch, Accovion GmbH (Size: 326 Kb)

CS02: Creating bar charts using the proc gplot and annotate function
Berber Snoeijer, Gerard Hermus Biometric Support (Size: 37 Kb)

CS03: Preliminary data process
Antoine Brisacier, Sanofi-aventis (Size: 148 Kb)

CS04: Check for SAS files consistency
Arnaud DAUCHY, Sanofi Aventis (Size: 347 Kb)

CS05: Runtime funtime: Vertical data reporting using runtime formats
Michael Auld (Size: 127 Kb)

CS06: Comparison of different ways using table lookups on huge tables
Ralf Minkenberg, Boehringer Ingelheim Pharma GmbH & Co. KG (Size: 59 Kb)

CS07: A SAS Macro for breaking pages
Michael Knoessl, Boehringer Ingelheim Pharma GmbH & Co. KG (Size: 46 Kb)

CS08: Advanced RTF layout with SAS
Katja Glass, Bayer Schering Pharma AG (Size: 191 Kb)

CS09: OSR - Output macro system with Proc report and central storage..
Peter Gerber, Genzyme (Size: 229 Kb)

CS11: An animated guide: The Amazing SQL Optimizer...
Russ Lavery (Size: 39 Kb)

Data Management

DM01: From local lab to standards and beyond
Angelo Tinazzi, Irene Corradino, Enrica Paschetto, Sonia Colombini SENDO-Tech S.r.l. (Size: 246 Kb)

DM02: Integrating data transformations using DI Studio and SAS DD
Alistair Dootson, Dootsonic Ltd (Size: 729 Kb)

DM03: Preparing real world data in Excel sheets for stats analysis
Volker Harm, Bayer Schering Pharma AG (Size: 42 Kb)

DM04: DQC checker
Ryan Finch, Roche Products Ltd (Size: 89 Kb)

DM06: Clinical data standards and automation
Giri Balasubramanian, Kinship Technologies Pvt. Ltd. (Size: 664 Kb)

Industry Starters

IS01: An animated guide: A map of the macro system
Russell Lavery (Size: 736 Kb)

IS02: Validation of programs developed using SAS
Nikos Tsokanas, Roche Ltd (Size: 151 Kb)

IS03: Automating GREPLAY to display multiple graphs per page
KarolAnne Fitzpatrick & Erika Daly, ICON Clinical Research (Size: 96 Kb)

Microsoft Tools

MT01:   How to write and track additional requests using Excel/Word
Xavier Passera, Detour Solutions Ltd. (Size: 138 Kb)

MT02:   WEB-TRIAGE: Application for patient registration in ph I studies
Angelo Tinazzi, SENDO-Tech S.r.l. & Lucio Ferraresi & Paolo Ferroni, Eventi Telematici (Size: 469 Kb)

Oracle Clinical

OC02:   Having your cake & eating it: extracting data and attrib from OC
John Hendrickx, Clinquest Europe (Size: 66 Kb)

OC03:   Data management metrics: how to use our instruments
Cristina Anselmi, Cros NT (
Size: 99 Kb)

Professional Development and Training

PD02: Intelligent outputs - telling the story
Claire Hoggins, Glaxosmithkilne (Size: 19 Kb)

PD03: A dedicated programming group in a pharma M&S organization
Vincent Buchheit, Novartis (Size: 233 Kb)

PD04: The ABC's of Offshore Survival
John Moone, ICON Clinical Research (Size: N/A)


PO01: Anticipating user issues with macros
Lawrence Heaton-Wright, Quintiles, (Size: 55 Kb)

PO02: Document stapling with C#
Mark Vanderstay, Amgen Ltd (Size: 343 Kb)

PO03: Electronic record validation
Erik Leijskens, Sini Marant & Wilfried Willems, Johnson & Johnson Pharmaceutical (Size: 10 Kb)

PO04: Medical safety review
Marleen Nijs, Ilse Augustyns & Heidi Curinckx, Johnson & Johnson Pharmaceutical (Size: 610 Kb)

PO05: ARROW statistical graphical system
Ann Cuijpers, Raphael Noirfalise & Romana Petrovic, Johnson & Johnson (Size: 102 Kb)

PO06: In-line formatting
Duong Tran, Independent Consultant (Size: 49 Kb)

PO07: %RiTEN
Duong Tran, Independent Consultant (Size: 59 Kb)

PO08: PK data file(s) creation process
Ann Cuijpers, Hilde Wuyts & Iris Van de Vliet, Johnson & Johnson  (Size: 43 Kb)

PO10: Compute; Your future with Proc Report
Ian J Dixon & Suzanne E Johnes, GlaxoSmithKline (Size: 166 Kb)

PO11: The Good, the Bad and the Ugly of programming standard
Rebecca Tootell, AstraZeneca and Natalie Collier, AstraaZeneca

PO12: The perfect reporting system - theoretically
Laura Phelan & Magnus Mengelbier, Merck Serono International S.A (Size: 70 Kb)

PO13: Relationships between ORRES and other CDISC variables
Susan Fehrer, BioClin Inc. & Russ Lavery (Size: 276 Kb)

PO14: A systematic review of PhUSE
Angelo Tinazzi & Anna Compagnoni, SENDO-Tech S.r.l. & Martin Scott, Numerus Ltd (Size: 49 Kb)

PO15: Integrating information - from char strings to SAS data libs.
Kamila Duniec, Oxford Pharmaceutical Sciences (Size: 203 Kb)

CDISC and Regulatory

RA01: Standardizing FDA data to improve success in pediatric drug development
Julie Maddox & Chris Decker, SAS Institute (Size: 209 Kb)

RA02: A SAS based solution for define.xml
Monika Kawohl, Accovion GmbH (Size: 481 Kb)

RA03: Relationships between CDISC variables concerning day and date
Susan Fehrer, BioClin Inc. & Russ Lavery (Size: 216 Kb)

RA04: Relationships between CDISC variables linking domains (relrec)
Susan Fehrer, BioClin Inc. & Russ Lavery (Size: 213 Kb)

RA05: Standardization of submission data sets and analysis data sets
Yvane Boudraa, Sanofi-Aventis Pharma (Size: 118 Kb)

RA06: MDMAP: An application utilized in the mgmt of trial metadata
Herve Guimard & Eric Sorel, Sanofi-Aventis Pharma (Size: 257 Kb)

RA07: Presentation of the demo of standardization of the ADS/SDS
Claude Guyot, Sanofi-Aventis Pharma (Size: 152 Kb)

RA08: All roads lead to SDTM - which one shall we take?
Ian Fisher, Meena Rahman & Donna Thompson, AstraZeneca (Size: 58 Kb)

RA10: Considerations for CDISC implementation
Robert T. Stemplinger & Jackie Lane, ICON Clinical Research (Size: 36 Kb)

RA11: Electronic submissions - the role of the programmer
Simon Dundas, Pfizer Global Research & Development (Size: 564 Kb)

Statistics and Pharmacokinetics

ST01: Using SAS to perform a stratified t-test
John Salter, Oxford Pharmaceutical Sciences Ltd (Size: 80 Kb)

ST02: Reporting of NONMEM Models using S-PLUS
Richard Pugh, Mango Solutions (Size: 272 Kb)

ST03: Bootstrapping in a replicative bioequivalence study
Feryal Tanriverdio & Arne Ring, Boehringer Ingelheim Pharma GmbH & Co KG (Size: 391 Kb)

ST04: Using the ARRAY statement to create ESTIMATEs and CONTRASTs
Roel Straetemans, Janssen Pharmaceutical & Franky De Cooman, GBSC (Size: 90 Kb)

ST05: Consideration of endogenous backgrounds in PK analyses
Fritz Schindel, Accovion (Size: 51 Kb)

ST06: Data mining in the clinical research environment
Dave Smith, SAS (Size: 153 Kb)

ST07: Bayesian Modelling with SPLUS and the S+flex Bayes library
Andrew Jack, Dawn Woodard, Joel Hoffman & Michael O'Connell, Insightful Corporation (Size: 416 Kb)

Technical Solutions

TS01: My Word, it’s a table of contents
John Woods & Esther Bayon, ICON Clinical Research (Size: 108 Kb)

TS02: First time in human reporting
Dylan Browne, Mango Solutions (Size: 73 Kb)

TS03: Graph automation using integrated SAS/S-PLUS solution
Qian Wang & Carl Herremans, MSD (Europe), Inc. (Size: 41 Kb)

TS04: Standard Management Approved Report Templates
Gary Stevens, Biogen Idec Ltd (Size: 230 Kb)

TS06: Clinical Research Information Management...
Dave Handelsman, SAS (Size: 135 Kb)

TS07: Standard Graph Templates
Philip R Holland, Holland Numerics Limited (Size: 229 Kb)

TS08: The value of metadata
Bas van Bakel, OCS Consulting (Size: 461 Kb)

TS09: Reporting by Elements - A New Way of Looking at Clinical Reports
Magnus Mengelbier, Limelogic  (Size 209 Kb)

TS10: Using tagsets MSOffice2k to customize your Excel report
Dominique Pinet, KEYRUS Biopharama (Size: 265 Kb)

TS11: Using SAS stored processes and the SAS portal...
Volker Harm, Bayer Schering Pharma AG (Size: 338 Kb)

TS12: Running clinical trials programs with Enterprise Guide
Philip R Holland, Holland Numerics Limited (Size: 123 Kb)


TU01: Introduction to the SAS9 Business Intelligence platform
Greg Nelson, ThotWave Technologies (Size: 2277 Kb)

TU02: Architecting SASin a Modern World..
Greg Nelson, ThotWave Technologies (Size: 2290 Kb)

TU03: A gentle introduction to Meta-analysis
Angelo Tinazzi, SENDO-Tech S.r.l & Jayne Tierney, UK Medical Research Council (Size: 296 Kb)

TU04: Quoting macro variable references
Shan Lee, GlaxoSmithKline (Size: 196 Kb)

TU05: They SQL Here, They SQL There
Ian Amaranayake & David Shannon, Amadeus Software Ltd. (Size: 85 Kb)

TU06: Proc format - tricks and traps
Christof Binder, BIOP Biometrical Practice (Size: 135 Kb)

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