Programme Day One

Tuesday 23 February 2010

8:30 Registration

9:00

Andy Lawton
Head of Biometrics & Data Management
Boehringer Ingelheim (UK)

Opening remarks from the Chair

STREAMLINING DATA PROCESSES AND REDUCING COSTS THROUGH THE EFFECTIVE APPLICATION OF STANDARDS

9:10

Pierre Verroye
Executive Director, Clinical Data Management and Clinical Programming
Human Genome Sciences

Overcoming obstacles in standardization to improve data collection

CDASH data collection standard and how it maps to the SDTM
Dealing with counterintuitive naming conventions and problems for SAS programmers
Understanding practical implementation goals for better results
Facilitating interoperability between clinical systems including data from EHRs and between numerous clinical data systems and trial sites
Identifying when standards help and when they threaten productivity

09:50

Scott Getzin
Data Scientist
Eli Lilly

Ensuring Consistency in Clinical Data Communication

Content vocabulary is the foundation for data standards
A common industry vocabulary is needed
Discussion on Lilly's approach and contribution to the cause
Clinical research and healthcare have different needs and processes
Industry alignment on messaging and content are key

10:30 Morning Refreshments

IMPROVING RESOURCE ALLOCATION TO ENHANCE DATA RELIABILITY AND TRIAL OUTCOMES

11:15

Pierre Verroye
Executive Director, Clinical Data Management and Clinical Programming
Human Genome Sciences

Darlene Kalinowski
Associate Director, EDC Operations
Bristol-Myers Squibb

Panel Session: Increasing data reliability in a globalized trial environment

What are the best practice approaches to coordinating data management functions across multiple international trial sites to achieve consistent reliable observations and outcomes?
How to decide upon the division of resources for maximum cost effectiveness
Outlining practical collaboration tools and techniques to keep the data moving and prevent blockages
Solutions for monitoring, reporting and administering global trials

12:00

Shawn Wang
President and CDISC BOD
Medxview

Implementing New standards: Bridging the gap between data management and regulatory affairs

Organizational benefits of implementing global standards such as hl7 and CDISC
Developing a common language for data management and regulatory affairs
Removing unnecessary hurdles in your daily duties and improving performance
Firsthand experience in avoiding submission data issues
The future is here...what is your next step to ensure success?

12:30 Lunch and networking

SUSTAINABLE OUTSOURCING STRATEGIES FOR COST EFFICIENT DATA MANAGEMENT

2:00

Katherine Arbour
Director, Clinical Data Management
Ariad Pharmaceuticals

Case Study: Hybrid CRO and sponsor partnerships to produce cost-effective outcomes for global EDC oncology trials

Determining the participants and allocating responsiblities and decision-making to each
Understanding the site's relations with EDC and mimizing the tool's capabilities
Determining critical paths in EDC trials designed for large, global oncology trials
Cost-effective models for CRO and sponsor hybrid approaches to managing data collection in an EDC trial

2:30

Nidhi Bajpai
Manager - Clinical Data Management
Panacea biotec LTD

Case Study: Outsourcing Clinical Data Management in India

3:00

Katerine Arbour
Director, Clinical Data Management
Ariad Pharmaceuticals

Shawn Wang
President
MedXView

Ram Kamath
President
V Soft

Nidhi Bajpai
Manager - Clinical Data Management
Panacea Biotec LTD

Panel Session: Getting best results from outsourced data management functions

Strategies for achieving cost effective data management in the current economic climate
Managing the opportunities and risks of different outsourcing options
Avoiding costly mistakes by choosing the right partner to fit the needs of your trial
Keeping control through optimizing timelines and costs in the data management process

3:45 Afternoon refreshments and networking

4:15

Terry Katz
Head of Data Management
Imclone Systems

Getting from data capture to a ‘clean’ data set

Establishing a data plan to minimize data leakage and waste in transit
Taking the data from front end capture to integrated database without compromising data integrity
Collating data from eCRFs, ePRO and EDC platforms while maintaining data safety and privacy
The use of data cleaning plans to provide a framework for data integration

MAXIMIZING THE USE OF EDC TOOLS FOR SIMPLER, CHEAPER AND QUICKER DATA MANAGEMENT

4:45

Darlene Kalinowski
Associate Director, EDC Operations
Bristol-Myers Squibb

How to realize the benefi ts of EDC in trials conducted in emerging countries

Successfully managing trial circumstances affecting operability of EDC tools
Overcoming lack of technology infrastructures in clinical trials in emerging countries
Solutions to communication problems in locations that cannot support EDC
Identifying hidden costs of the trial environment - the impact on data capture and integration

5:15 Closing remarks from the Chair and close of Day One