Increase
the speed and accuracy of your data collection through
Process Improvement in Clinical Data Management
Chair: Nigel P Barker Director of Data Management Bristol-Myers
Squibb
Nigel Barker qualified as a statistician, before
working for 15 years at ICI Pharmaceuticals, now Zeneca, in various positions in
statistics and systems development. In 1989 he joined E. R. Squibb in London as Director
of Clinical Data Management. Following the merger with Bristol-Myers he moved to Belgium
at the end of 1990. His department is responsible for the handling of all BMS European
Phase I-III studies.
09:00 Registration and coffee
09:30 Opening remarks from the Chair
09:40 Implementing key performance
indicators to apply the process of
continuous improvement in clinical data management
- Measuring the effectiveness of clinical data management in terms of time, volume,
quality, use of standards and required support
- Deciding whether to compare whole studies or different progress points within a
single study
- Determining what the most appropriate and realistic measures should be, and
defining the optimum data points to collect and support your metrics
- Using appropriate methods to display and disseminate the results of performance
measurement in a rapid and structured way
- Ensuring that performance measurement in clinical data management is developed as
a proactive tool in the continuous improvement process
Dr Kurt Löffler
Head of Clinical Data Management
Hoechst Marion Roussel
Kurt Löffler PhD has been head of Clinical Data Management with Hoechst
Marion Roussel Germany since 1996. Previously, he has held positions as
biostatistician with Hoechst and as Head of Biometry and Data Management at Cassella, a
German Hoechst subsidiary. Before joining the Hoechst group, he worked several years in
biomedical research with the Max-Planck Institute of Psychiatry in Munich. Dr
Löffler is a Mathematician and Computer Scientist by training, and holds a PhD
in Psychology. |
10:20 Effectively managing your data management department
- Prioritising workload in over-stretched departments
- Overseeing the relationship between clinical data management, statistics,
clinical and regulatory affairs and ensuring feedback to facilitate continuous improvement
- Effectively maximising the skill base of staff members: the ‘horses for
courses’ effect
- Clearly defining roles and responsibilities to effectively benchmark staff
performance
- Overcoming cultural resistance to change when retraining and streamlining
clinical data management and biometrics
- Reducing the impact of inertia following project completion
- Making optimum use of world-wide resources
Nigel P Barker
Director of Data Management
Bristol-Myers Squibb
11:00 Morning Coffee
11:20 Re-engineering your data collection processes to minimise the
duplication of work in a clinical data management - clinical trials environment
- Mapping existing procedures for the collection and processing of clinical data
within the clinical trial environment
- Identifying possible areas of duplication and understanding why they exist
- Redefining both individual roles and inter-department interfaces in order to
maximise efficiency whilst maintaining quality
- Evaluating the consequences of implementing process and procedural changes
- Setting clear procedural guidelines to maintain the flow of quality data
Harshad Sodha
Head of Biometrics
Verum Til Occam
After completing a degree in Microbiology at the University of London, Harshad
Sodha spent 4 years lecturing mainly in Biological Sciences. In 1989, he moved
into the rapidly expanding area of Clinical Data Management. Mr Sodha’s
experience in CDM spans 9 years, two at SmithKline Beecham, two at Ciba Pharmaceuticals
and three at Scotia Pharmaceuticals as manager of the data management team. In 1996, he
entered the CRO environment as Head of Biometrics at Verum Til Occam. Mr Sodha is
an active member of the ACDM, and since 1993 has been involved in the Academic
Sub-Committee, responsible for setting up the MSc in Clinical Data Management running in
partnership with Kingston University.
12:00 Improving speed and efficiency through the process and system
redesign of
clinical data management operations
- Reviewing current processes, systems and capabilities to identify where
improvements can be made
- Pinpointing where improvements will have the greatest impact
- Identifying the strengths and weaknesses in traditional paper-based forms of data
communication
- Improving data quality by moving data review closer in time and space to data
capture
- Evaluating the cost/benefit ratio of switching to ‘advanced’ clinical
data management
Don Rosen
Partner
CSC Healthcare Life Sciences
Mr. Rosen is a Partner with the Life Sciences Group the CSC
HealthCare division. He has over 30 years of international experience
enabling business process improvement with state-of-the-art information technology.
He has experience in management and technical consulting engagements in pharmaceutical
R&D, securities and commodities trading, factory automation, communications,
networking, and real-time systems. Mr. Rosen has spent the last 6
years working with Pharmaceutical industry clients, particularly in R&D. He is a
frequent presenter at industry forums on the topics of document management and clinical
development process improvement and data management.
12:40 Lunch - Sponsored by 
14:00 Undertaking long-term project planning to effectively link your
data management and clinical trials activity
- Evaluating the pros and cons of establishing an international project team in
comparison to a decentralised multi-centre approach
- Structuring cross country and inter-departmental meetings to co-ordinate staff
and resource allocation to the project
- Effectively communicating your long-term objectives to all project team members
- Empowering your team to make decisions whilst maintaining the balance with
corporate objectives
- Examining strategies to motivate the project team and achieve results within the
desired time frame
Andy Williams
Director, Medical Data Sciences
Glaxo Wellcome Inc
Andy Williams gained an MSc in Toxicology from the University of
Birmingham in 1985. He joined Glaxo Research & Development in 1986
following a brief period as a Research Assistant at Zeneca Pharmaceuticals, where he acted
as Head of Database Reporting and Head of Medical Database Administration. Following the
integration of Glaxo & Wellcome in 1995, Mr Williams was appointed
Director of International Medical Affairs, responsible for providing strategic data
management and statistics support for Global Corporate Marketing. He is currently on a
long-term secondment as Director of Medical Data Sciences for Glaxo Wellcome
Canada Inc.
Strategic direction issues
14:40 Effectively motivating clinical data managers in the changing data
management environment
- Dealing with the specific cross-cultural issues which arise through merger,
reorganisation or process reengineering
- Defining the purpose and benefits of change for the clinical data manager and the
data management environment
- Gaining commitment for change through participation and effective communication
- Setting objectives that are SMART (specific, measurable, achievable, relevant and
timely) to facilitate and implement change
- Overcoming the potential for conflict when balancing individual and team
objectives
- Providing the appropriate training, data management systems and support to
facilitate the transition to new defined roles and responsibilities
Dr Winfried Koch
Eva Hammarström-Wickens
Head of Biometrics & Data Management
Head of Data Management
BASF Pharma
Knoll Pharmaceuticals
 Starting
his career as a mathematician at the BASF computing centre, Dr
Winfried Koch went on to become responsible for biometrical support in biology
and health medicine at BASF. In 1976 he became Head of Biometrics at BASF
Pharma, and in 1982 Head of Biometrics and Data Management at BASF Pharma.
Since 1995 he has been involved in various ways in managing change both with the merger
with Boots and in the acceleration of clinical development at Knoll AG.
 Following
her studies at Gothenburg University, Eva Hammarström-Wickens worked for
eight years at AB Hassle as Assistant Director for the data management of gastrointestinal
clinical trials. From 1987to 1989 Eva was based at Astra Pharmaceuticals in the UK as a
Statistician/Data Co-ordinator. Eva is currently employed with Knoll
Pharmaceuticals as Head of Data Management. Since 1995 she has been involved in
the global implementation of a new data management system and, since 1997, in a data
management reengineering project. Mrs Hammarström-Wickens also served on
the committee of the ACDM from 1993 to 1995.
15:30 Concluding the data management process to facilitate speedy
signing off of the final trial report
- Reducing the number of data points by trial design and simulation
- Ensuring effective data flow at every level to facilitate rapid process at end of
data process
- Speeding the unblinding of data and cleaning of files before the clinical study
report, summary are drawn up
- Co-ordinating data and overseeing the writing of the expert report
Dr Roman Görtelmeyer
Head of Department, Medical Biometrics & Data Management
Merz & Co GmbH
Dr Görtelmeyer started his career as a psychologist in the Clinical Research of E.
MERCK, Darmstadt, focusing on methodology and psychometrics in Phase I to III trials in
Psychneuropharmacology. After moving to Merz & Co, Frankfurt in 1985
he became responsible for biometrical support of preclinical and clinical research. In
1986 Dr Görtelmeyer became Head of the Department of Biometrics, and in
1995 Head of Medical Biometrics and Data Management at Merz Pharma.
16:10 Afternoon Tea
Hands on technical issues and CRO Management
16:30 Critical success factors in successfully outsourcing clinical data
management
- Assessing the cost implications and potential benefits of outsourcing your data
management and analysis
- Pinpointing when it makes sense to outsource and identifying which parts of the
data management process and information can be shred
- Selecting and auditing potential partners
- Clarifying and contracting the various responsibilities of CRO and sponsorá
Determining the appropriate levels for negotiation and day-to-day management
- Trouble shooting and defining quality control steps
- Co-ordinating several CROs when managing different partners to ensure consistency
of data
Dr Hans-Friedrich Koch
Head of Biometrics and Clinical Data Management
Solvay Pharmaceuticals BV
 After
obtaining an MSc in Mathematics from the University of Gšttingen, Dr
Hans-Friedrich Koch went on to work as a Project Statistician, and later Director
of Data Management, at the CRO 1AS Bielefeld. In 1992 he became Head of Biometrics at
Solvay Deutschland, Hanover. Before obtaining a PhD in Statistics from the University of
Hanover. In 1996 he was promoted to his present position of Head of Biometrics and
Clinical Data Management Europe at Solvay Pharmaceuticals in the
Netherlands.
17:10 Maintaining effective communication between sponsor and CRO to ensure
successful outsourcing of your data management - a Japanese industry view
- Establishing the compatibility of systems and procedures between sponsor and CRO
- Differentiating between CROs in terms of speed & data quality
- Ensuring trust and reciprocal information flow
- Establishing and maintaining progress through tracking and performance feedback
- Identifying problems, making criticism and handling conflict situationsá
Motivating the CRO to create a win-win relationship
- Working effectively within the CRO accountability-based environment
Mr Hiroshi Sugii
Director, Representative
Sankyo London Office
 Mr
H Sugii graduated from the Pharmaceutical Faculty of the University of Tokyo in
1984. He began his career at Sankyo with seven years the field of
antibiotics and cardiovascular drug development in Japan. In 1993 he transferred to Sankyo
Europe R&D, based in Germany, where he contributed to the European
development of several new products. Since 1997 he has been working in Sankyo
London Office supporting Japanese exploratory projects and Regulatory Affairs
work in Europe.
| 17:50 Closing remarks from the Chair 18:00
End of day one |
|
Cocktail Party
Drinks will be served to allow delegates to network in a more informal
environment. |
To
register call +44 (0) 171 915 5055 or send an Email |
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CDM '98 
