HUM-MOLGEN events: Optimising Drug Development Through Effective Data Management in Clinical Trials

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Optimising Drug Development Through Effective Data Management in Clinical Trials

March 21, 2001

SMi conferences, The Hatton, Hatton Gardens, London
9th & 10th July 2001

Day One – Monday 9th July

9.00 Chairman's Opening Remarks
Dr Alan Davies, Clinical Development Director, Kendle

INTRODUCTION

DATA MANAGEMENT WITHIN THE CLINICAL TRIAL PROCESS
9.10 Whys and hows of data management processes
 Overview of clinical trials data management
 Practical issues in data management
 Statistical requirements of clinical trials
 Legal issues in international clinical trials
 Monitoring clinical trials
 Web-based clinical trials
Lisa-Anne Markel, Executive Director, Global Data Management, Covance

STRATEGIC MANAGEMENT

STRATEGIES FOR IMPLEMENTING DATA MANAGEMENT STRUCTURES
9.40 Strategic clinical programme development
 Common data management problems
 Methods of improving current systems
 Effective structure implementation
 How to improve data quality and consistency
 Examples and experiences from industry
 What can we learn?
Malcolm Horseley and Andrew Gold, Principal Consultants, PA Consulting

STRATEGIES FOR OPTIMISING DATA COLLECTION
10.20 Case study: improving your data collection system
 Current methods implemented in data collection
 New approaches to effective data collection and management
 Benefits of using networked technology for data collection
 Use of flexible data management systems throught M.E.T.I.S.
 System implementation and improvements
 Future of e-data collection
Dr Edmund Otun, Managing Director, Metadata Solutions

11.00 Morning Coffee

GLOBAL STRATEGIES IN CLINICAL DATA MANAGEMENT
11.20 The increasing burden of global data management
 The effective management of global teams
 Challenges for distributed workflow
 Managing outsourcing partnerships for global programmes
 Is technology easing the burden for global data management?
 Effective project management strategies
Dr Jon Wood, Director, Global Data Management, Cromedica

INCREASING EFFICIENCY IN NEW DRUG APPLICATIONS BY EFFECTIVE DATA MANAGEMENT
12.00 Statistical strategies for data management
 Defining quality
 Levels of data validation
 Statistical tools for data validation
 Monitoring the queries
 Return on investment
 Statistics on status/quality flags
Dr Imogene Grimes, Executive Director Biostatistics & Data Management, Yamanouchi

12.40 Networking Lunch

PRACTICAL ISSUES

DATA MANAGEMENT SOLUTIONS
2.00 10 good ways to make clinical software work
 Are you getting the most from your clinical data?
 How to ensure effective data management
 E-solutions: how effective are they?
 Clinical software solutions: how to make the most of your IT software
 Data structuring: the benefits
 E-management for the next generation
Dr John Ryan, Managing Director, Plato

INCREASING BUSINESS INTELLIGENCE THROUGH WEB-BASED DEVELOPMENT DASHBOARDS
2.40 The clinical dashboard concept
 What are dashboards and where is pharma implementing them?
 What technologies can be used to develop dashboards?
 What information should be included on a dashboard?
 Improving data management using dashboards
 How can real-time data be collected from operational systems and presented via the dashboard?
 How will a dashboard impact on your clinical trial efficiency?
Dr C David Hardison, VP Strategy Services & Global Clinical Development, First Consulting Group

3.20 Afternoon tea

IMPROVING CLINICAL DATA THROUGH EFFECTIVE PATIENT RECRUITMENT
3.40 New tools for the healthcare frontier
 Current problems in clinical trial recruitment
 Effective patient recruitment to accelerate clinical trials
 Considerations of recruiting on-line: pros and cons
 Services offered by patient recruiters
 Improved methods to attract volunteers
 New generation of internet solutions for optimal recruiment
Dr Jörg Täubel, Managing and Medical Director, Charterhouse Clinical Research Unit

RETAINING CLINICAL DATABASE
4.20 Utilising the rapid advances in technology solutions
 Are we assured that a common clinical data source is used for repeated submissions of the same data?
 Single regulatory database identification and how it relates to other data collection
 Data manipulation in SAS and the risks involved
 Common treatment (quality checks, coding) of data regardless of source (EDC v paper CRF)
 Data accumulation from CROs, co-developers, local group companies
 Responding to unexpected regulatory requests
Barry Burnstead, Senior Business Consultant, Clinsoft

5.00 Chairman’s Closing Remarks and Close of Day One

5.10 NETWORKING DRINKS RECEPTION

Day Two – Tuesday 10th July

8.30 Re-registration and Coffee

9.00 Chairman's Opening Remarks
Dr Stephen Donoghue, Director, Clinical Affairs, Elan Pharma

ELECTRONIC MEDIA

CLINICAL TRIALS IN THE INFORMATION TECHNOLOGY ERA
9.10 Assessing your IT infrastructure and looking ahead
 Current information technology in clinical trials
 Building a bridge from traditional to e-trials
 Impact of new IT technology to date
 How can you assess your IT requirements
 Resourcing EDC projects with the right staff
 Data flow in electronic trials, now and in the future
Helen Parker, Development Director Webcollect Europe, Quintiles UK

USE OF ELECTRONIC DATA CAPTURE FOR CLINICAL TRIALS
9.40 Case study: does EDC improve data quality?
 Overview of electronic data capture technology
 Current problems with data entry
 Data quality and cost analysis: experiences at Kendle
 Improvements in EDC technology
 EDC applications in multinational clinical studies
 Where next?
Tom Ruane, Associate Director of Site Management, Kendle

E-CLINICAL TRIALS – INTO THE FUTURE
10.20 Design and implementation
 Globalisation and co-ordination of clinical trials
 Manual vs electronic data entry: practical issues
 Use of computerised systems in e-clinical trials
 Do EDC trials improve efficiency of drug development?
Stuart Pearce, Team Leader, Electronic Data Capture, Pfizer

11.00 Morning Coffee

SUCCESSFUL STRATEGIES FOR ELECTRONIC DATA CAPTURE INTEGRATION
11.20 Computer system validation in clinical systems
 Available strategies for EDC
 Approaches to assess electronic data capture integrity
 Auditing computer systems used in clinical trials – tools and tips
 How to improve current validation protocols
 Monitoring and optimisation of EDC integrity
 Implementation of new strategies to ensure data integrity
Ann-Charlotte Nylander, Marketing Manager Northern Europe, Biomit

INFORMATION SYSTEMS FOR CLINICAL TRIALS
12.00 Global development and implementation
 Transition from traditional data management processing to an EDC environment
 How to manage global data: developing and utilising IT
 Data encryption in web-based systems
 Encoded access systems: what are the benefits?
 Monitoring systems in data management
 Data protection for the next generation of web-based reporting systems
Dr Ursula Schwuttke, President & CEO, Hightower

12.40 Networking Lunch

E-PROCESS IN CLINICAL TRIALS
2.00 Developing a deployment model for use of EDC
 Why EDC?
 Establishing the framework
 Metrics & KPIs
 EDC deployment model
 Outcomes
 Future use of EDC for trial management
Paul Messis, Marketing Director, TEAMworks Clinical Services

REGULATORY ISSUES

REGULATORY REQUIRMENTS FOR WEB-BASED CLINICAL TRIALS
2.40 Protection of clinical data
 Compliance with regulations and guidelines for e-clinical trials
 New legislation for e-clinical trials
 Systems validation
 E-learning and training in clinical data management
 Legal protection and intellectual property rights of e-clinical trials
 Data protection and the implications for data processing
James Wang, Director Database Management & Programming, Allergan

3.20 Afternoon Tea

ADVERSE DRUG REACTION REPORTING IN CLINICAL TRIALS
3.40 Real-time ADR reporting
 Use of e-based ADR reporting systems
 Implementation of e-based systems
 Information integration throughout different therapeutic fields
 Advantages of e-based ADR reporting systems
 Improving consistency of ADR reporting
 Ensuring effective communication of ADRs to regulatory bodies
Marty Boom, Senior Managing Consultant, WCI Group

INTELLECTUAL PROPERTY ISSUES IN E-CLINICAL TRIALS
4.20 Data exclusivity and patent protection
 Data protection rights: striking a fair balance
 Evolution of the regulations encompassing e-clinical trial data
 Existing patent protections strategies for data protection
 Legal issues for data recycling
 Patentable data – dispute tactics and validity
 Commercial use: fair competition
Diana Sternfeld, Senior Partner, Willoughby & Partners

5.00 Chairman's Closing Remarks and Close of Conference

Organized by:

Louise Maher

Invited Speakers:

 James Wang, Director Database Management & Programming, Allergan
 Dr Imogene Grimes, Executive Director of Biostatistics & Data Management, Yamanouchi
 Stuart Pearce, Team Leader, Electronic Data Capture, Pfizer
 Tom Ruane, Associate Director of Site Management, Kendle
 Helen Parker, Development Director Webcollect Europe, Quintiles UK
 Dr Jon Wood, Global Director Data Management, Cromedica
 Lisa-Anne Markel, Executive Director, Global Data Management Covance
 Dr Jörg Täubel, Managing and Medical Director, Charterhouse Clinical Research Unit
 Ann-Charlotte Nylander, Marketing Manager Northern Europe, Biomit
 Dr John Ryan, Managing Director, Plato
 Paul Messis, Marketing Director, TEAMworks Clinical Services
 Barry Burnstead, Senior Business Consultant, Clinsoft
 Malcolm Horseley and Andrew Gold, Principal Consultants, PA Consulting
 Dr C David Hardison, VP Strategic Services & Global Clinical Development, First Consulting Group
 Marty Boom, Senior Managing Consultant, WCI Group
 Dr Edmund Otun, Managing Director, Metadata Solutions
 Dr Ursula Scwattke, President & CEO, Hightower Software
 Diana Sternfeld, Senior Partner, Willoughby & Partners

Chaired by:
 Dr Alan Davies, Clinical Development Director, Kendle
 Dr Stephen Donoghue, Director Clinical Affairs, Elan Pharma

Deadline for Abstracts:

No abstracts required

Registration:

£1099 + VAT

E-mail:

customer_services@smi-online.co.uk

Posted by:

Louise Maher

Host:

213.38.112.46