 Maintaining quality in Clinical
Data Management
Chair: David Morgan
Head of Biometrics & Data Management Europe Hoechst Marion Roussel
Following a short period in the Government Statistical Service, David
Morgan lectured for nine years at Cranfield University. He entered the
pharmaceutical industry in 1986 with Wyeth, then moved to Beecham/SB, holding positions of
increasing responsibility in Statistics and Clinical Data Management both in Europe and
the US before moving to Hoechst Marion Roussel. Dr Morgan
is a Chartered Mathematician and Chartered Statistician, and was Chairman of PSI
(Statisticians in the Pharmaceutical Industry) from 1995 to 1997.
09:00 Registration and coffee
09:30 Opening remarks from the Chair
09:40 Case study: Maintaining consistency by developing effective core
standard operating procedures (SOPs)
- Identifying the benefits of developing standard cross-departmental procedures to
minimise the impact of staff turnover and facilitate the transition between clients
- Tailoring your core data management SOPs to reflect the idiosyncrasies of each
project - a CRO perspective
- Implementing a continuous improvement mechanism to ensure SOPs are current best
practice
- Ensuring that your internal procedures are in line with international
requirements
- Undertaking the structuring of global SOPs and local guidelines to ensure
compliance at all locations
Maria MacGarvey
Head of International Data Management
IBAH
Mrs MacGarvey began her career in CDM at Cynamid, where she was a data
co-ordinator working primarily on anti-infectives. In 1991 she joined Glaxo
Pharmaceuticals UK as a data analyst in the gastrointestinal and dermatology therapeutic
areas. She moved across into contract research by assisting in the development of
the European CDM department at ClinTrials Research. In January 1997, Maria
moved to Head the International CDM Department at IBAH in Chippenham,
where she has recently been involved in re-writing their global CDM and local
departmental procedures.
10:20 Minimising the percentage of invalidated studies through good
auditing of systems and people
Using audit as a proactive tool for systems and process
improvement
Formulating an audit checklist which accurately reflects the key
data issues
Determining the frequency and timing of quality control checks
Ensuring effective communication flow between the quality
assurance and clinical development departmentsá Balancing the pros and cons of
establishing a separate in-house data quality control department
Looking at the potential to develop international standards from
a clinical data audit
John Alexander Deputy Director
Research Support & Information Services
Roche Bioscience USA
John Alexander joined the California-based Roche Bioscience
in 1995 from the UK, where he worked as Manager, Clinical Quality & Technology at
Syntex Research. From 1986 to 1991 Mr Alexander was Head of Statistics
& Data Management at Hazelton and then Besselaar in Harrogate and Leeds, where he was
mostly involved in the Phase I and pre-clinical areas. He has extensive data management
experience in both clinical and preclinical research and, as a Chartered Statistician,
many years experience as a University Lecturer and consultant in Medical Statistics.
11:00 Achieving thorough and efficient auditing by harmonising your
internal quality assurance procedures with regulatory inspections
Establishing
a separate audit unit independent of your clinical data processes
Minimising
risks by early auditing of study packagesá Maximising the value of the clinical
investigator audit to the clinical project team and the investigator
Harmonising
your internal audit requirements with the needs of regulators to increase the speed and
efficiency of product registration
Developing
a feedback loop to implement corrective actions when necessary
Dr Hans Poland
Head of Good Clinical Practice
Schering AG
Hans Poland has been with Schering AG since 1973, where
he began as a Scientific Co-ordinator in fields including pharmacokinetics and automated
data analysis. He went on to be a Manager in Physics R&D before becoming Head of the
Medical Services Department in 1984. In 1991 he was made Head of Computer Systems for
Clinical Development, responsible for implementing a Global Drug Safety System, Clinical
Data Management System and Clinical Study Administration and Monitoring System. Dr
Poland has held his current position as Head of Good Clinical Practice since
1996.
11:40 Morning coffee
12:00 Benchmarking your data management: designing tools and techniques
to effectively monitor the quality of your data and data management processes
Designing
performance measures to meet your corporate goals and the regulator’s requirements
Setting
the organisational context for meaningful performance measurement and benchmarking
Ensuring
you monitor the right indicators of performance
Defining
the optimum data points to collect benchmarking information
Comparing ‘like for like’ in order to achieve meaningful
results
Developing effective internal performance indicators on the basis
of your findings
Rhona Allison
Associate Director Data Management
PPD Pharmaco
Following her degree in Biological Sciences, Rhona Allison
joined DAR, a contract research organisation, to initiate the Quality Services Department,
which was responsible for ensuring company-wide compliance with Standard Operating
Procedures (SOPs). After establishing the department, she was appointed Head of Data
Management. When PPD Pharmaco acquired DAR in 1996, Rhona was appointed
Associate Director, Data Management (Europe). Rhona is involved with the Association of
Clinical Data Managers, having served on the main committee for three years and remaining
an active member of the Conference Sub-Committee.
12:40 Interactive benchmarking session
Speakers and delegates will have the chance to share their experiences and ideas on
how to effectively monitor the quality of your data in a CDM environment
13:00 Lunch
14:00 Ensuring that the quality of data is maintained, timelines are met
and good clinical practice (GCP) guidelines are followed when you outsource your clinical
data management
Optimising
the sponsor/CRO relationship by adopting ICH GCP procedures
Pre-empting
contractual audit disagreements when drawing-up the initial agreement
Monitoring
the consistency of data collection and data management procedures
Understanding
what QA departments look for when undertaking investigator audits
Ensuring
the quality control of essential study documentation
Heather J Wells
Clinical Quality Manager - Northern Europe
Bayer PLC
After gaining an MSc in Biological Computation from the University of
York, Heather Wells joined Bayer in 1986 as a Clinical Data Analyst. She
was promoted to Clinical Data Management Manager, then Systems Compliance Manager with
responsibility for all GCP aspects of clinical data management and statistics, including
computer validation. In September 1995, Heather was appointed to her
current position of Clinical Quality Manager- Northern Europe, with a role expanded to
included investigator site and CRO audits, review of protocols and medical research
reports and the facilitation of Northern European and European SOP working parties.
14:40 Understanding the role of error rate calculation in the assessment
of database quality
Examining
the pitfalls of using error rate calculation to assess database quality
Addressing
the issues relating to the measurement of the consistency of data in the database
Examining
the relationship between error rate targets and the number of items sampled
Designing
and implementing more robust sampling strategies
Deciding
whether errors detected in the database audit should be corrected
Andy Garrett
Associate Director Biostatistics
Quintiles UK Ltd
Andrew Garrett has a BSc in Economics from the University of Leicester and a MSc in
Medical Statistics from the University of Newcastle upon Tyne. He has worked in the
pharmaceutical industry for 13 years. Before joining Quintiles, he was a
statistician for Warner Lambert and Parexel, and for 6 years was Manager, Clinical
Statistics at the Cyanamid European Data Centre. Andy is currently
working for a research degree with the Open University.
13:20 Afternoon Tea
15:40 Clarifying to what degree you need to validate electronic data
entry systems
Deciding who should be involved in the validation process
Identifying what needs to be included in the validation process
Defining appropriate methods for validation
Achieving and maintaining the validated state of your systems
Jennifer Cole MBA
Quality Assurance Associate
Covance Clinical and Periapproval Services Ltd
Jennifer Cole MBA has over 10 years experience in IT project
management and the design and implementation of Quality Systems for ISO 9001, gained in
both the healthcare sector and IT industries. At Covance CAPS she was
recently responsible fort he design and implementation of a Quality System for Covance
European Information Services Division. She is currently working for the Regulatory
Affairs Unit where she is responsible for providing consultancy services on validation
issues and undertaking compliance systems audits.
16:20 Improving the quality, speed and efficiency of your data
collection by implementing Electronic Data Capture (EDU) in your clinical trials
- Evaluating electronic data capture opportunities: emerging solutions
- Evaluating the cost effectiveness of electronic data capture versus traditional paper
methods in terms of speed, efficiency, quality and security
- Ensuring a smooth transition to using EDC
- Effectively selling the benefits of EDC to your organisation
- Monitoring compliance and overcoming technical hitches
- Establishing methods to effectively archive your EDC records
Alistair Shearin
Head of European Clinical Systems Team
Coopers & Lybrand
Alistair Shearin has been working in pharmaceutical systems for over 10 years.
His recent emphasis has been on R&D systems, focusing particularly on Clinical
Data Management. Areas of interest within data management included data capture and
reporting, and the use of information systems in clinical trials programmes with a view to
re-engineering the trails management process. Before jointing Coopers &
Lybrand, Mr. Shearin working for ICI in Project Management Systems Building.
17:00 Closing remarks from the chair, end of day three and close of CDM
‘98
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CDM '98 
