P001

SAS

Conducting a Successful

SAS/PH-Clinical Software

Implementation

Tasha Kostantacos, Brian Fredric SAS Institute, Europe

609

P002

SAS

Acknowledgement

SAS/PH-Clinical Software:

CANDA Implementation Strategies

J. Meimei Ma, Quintiles Inc. Sandra D. Schlotzhauer, SAS Institute Inc.

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P003

SAS

Pharmaceutical/Biotechnology Challenge:

Reduce Time to Market

with CANDA

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P004

SAS/PH-Clinical SAS

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POOS SAS

SAS/PH-Clinical Software

Highly Effective, Flexible, Productive Environment

Fuctionality Includes: Clinical Data Access, Management,

Analysis, Reporting & Review

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P005a

SAS/PH-Clinical SAS

Global Applications

Generate Patient Groups

Explore and Analyse Data

Create Reports and Graphics

Evaluate Overviews

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SAS/PH-Clinical SAS

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Global Benefits

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Flexible, Intuitive Environment 1,":,"

Data Driven

Transparent Data Access

Error-Free Application Code

Effective, Efficient Data Review

Industry Specific Application

616

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P006

SAS/PH-Clinical

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SAS

User Audience:

Biometricians

Clinicians f·:·.·····

Regulatory Affairs

Product Administrator (PA)

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P007

SAS/PH-Clinical

Biometricians

Sophisticated Analysis of Clinical Data

Exploratory Data Analysis

Reporting Tools

SAS Code Generated

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P008

SAS/PH-Clinical

Biometric A'pplications

SAS

Proc Freq, Proc Report, Proc Univariate, etc

Incorrect Syntax ???

Missing Semi-Colons ???

Unbalanced Comment Delimiters

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P009

SAS/PH-Clinical

Biometricians : Benefits

Optimize Skills and Time

Utilize Professional Skills Effectively

Reduce Data Management

Reduce Programming Time

620

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P010

SAS/PH·Clinical

Clinicians: Applicat,ions

Monitor Accumulation of Patients

Recognize & Report ADEs

Preliminary Review

621

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SAS/PH-Clinical SAS

Clinicians: Scenario

Patient Reports from Biometrics

ADE Reports

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P011

SAS/PH-Clinical SAS

C:linicians : Benefits,'

Effective Monitoring of Trial's Data

Tools,to HandleADEs

Ability to Share Information

623

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P012

SAS/PH-Clinical SAS

Regulatory Affairs: Applications

On-Going Review Facility

Tools for Data, Output, Graphics Review

Communications between Sponsor and Agency

624

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P012a

SAS/PH-Clinical SAS

Regulatory Affairs: Scenario

CANDA Teams

625

P013 f

.~ SAS/PH-Clinical SAS

Regulatory Affairs: Benefits

Common, Standard Interface

Reduction in Compilation Time

Reduction in Paper

626

P014

SAS/PH-Clinical SAS

Product Administrator

Defines Clinical Data and Studies

Manages User Profiles,

Security Gateways,

Output Devices,

Public Library

627

P014b

SAS/PH-Clinical SAS

PA Benefits

Open Shell for study definition

Performs once-off tasks

Provided greater control of environment

Frees up data management task for end-users

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P015

SAS/PH-Clinical

Implementation Strategy Involves:

Integrated Team Effort

SAS

In Depth Knowledge of Data and Structures

Technology Optimization

629

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Integrated Team:

Biostatisticians

Clinical Scientists , : :. -~ : .'

Regulatory Affairs

Information Systems (IS)

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SAS/PH-Clinical SAS

Integrated'Tea'm : Benefits

Common Tool

Improved Communications

Common Training

Central Coordinator

631

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P017

SAS/PH-Clinical SAS

1m plementation Strategy : DATA

Plan and Standardize Data Structures Early

KNOW YOUR DATA and DATABASE STRUCTURES!!

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P018

SAS/PH-Clinical SAS

Technology Optimization

Muli-Vendor Support , ; ... :

Client/Server Support

Industry Standards (eg GUI)

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633

P018b

SAS/PH-Clinical SAS

Technology Optimization: Benefits

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Same Look and Feel

Data Integrity

Flexibility

Optimization of Resources

634

P019

SAS/PH-Clinical SAS

Implementation Strategy i .

Integrated Plan

Team

Data

Technology

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P020

SAS/PH-Clinical

1m plementation Strategy SAS Institute Support

Assistance with Implementation Plan

Installation, Training, & Support

Documentation

636

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P021

SAS/PH-Clinical

Institute Papers

11 :30 Lee Evans SAS Institute Inc., US Product Status and Futures

SAS

16:30 Allan Reading SAS Software Ltd, UK . SAS/PH-Kinetics

637

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P022

SAS/PH-Clinical

Q & A Sessions

15:30 Pharmacetical Applications

17:00 Validation

Demonstration Area

638

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