CONFERENCE
 CDM '98
Day 1
Day 2
Third Day Focus
WorkshopWHY ATTEND?
26 Sessions!
9 Key Reasons
Who and Why?
Important Links
REGISTRATION
Free Brochure
Booking Form
Administration
©
IIR B.V. 1998 |
|
Increase
the speed and accuracy of your data collection through
Process Improvement in Clinical Data
Management
Chair: Paul Loughlin, Manager Biometrics
Projects Zeneca Pharmaceuticals
Paul Loughlin qualified as a statistician from
Edinburgh University. Before joining the pharmaceutical industry with ICI he worked in
both the nuclear and water industries. He has now been with Zeneca for
over 12 years and has worked in most areas of drug development. He has had responsibility
for Clinical Data Management at the Alderley part site for a number of years, and takes a
keen interest in this area. He is currently the Chairperson of the Association for
Clinical Data Management (ACDM).
08:30 Registration & coffee
09:00 Opening remarks from the ChairSystems, Technology and
Working Practice
Systems, Technology and Working Practice
09:10 Adapting working
practice in clinical data management in response to implementing new technologies
- Examining the impact of new technology on the roles and responsibilities of the
clinical team
- Developing a more reactive attitude to clinical trials by spotting emerging
trends early on
- Overseeing the training of investigators in remote data entry, optical character
recognition, and other new technologies
- Dealing with the changing of roles accorded by the cleaning data on entry
- Keeping a close eye on data quality as it comes in to spot errors and request
check-ups on a continuous basis day delay
Vanessa Tierney
Section Head, Data Management
Glaxo Wellcome R&D
 Vanessa
Tierney joined Glaxo, now Glaxo Wellcome, after leaving university. She spent
over four years in Data Management and four years in Clinical Research before returning to
Data Management in 1995. Ms Tierney manages teams conducting the day-to-day activities of
Phase I and II clinical trials, has worked extensively in Europe and was part of a team
designing the Glaxo Wellcome in-house database system at the US site in North Carolina.
She is currently heading a team of data scientists handling European Phase I and II trial
data for the cardiovascular, critical care, metabolic and oncology therapy areas. |
09:50 Examining the benefits and pitfalls of data
collection management tools and technologies
- Evaluating the various options: imaging, optical character recognition, scanning,
electronic diaries, electronic data transfer; fax technologies
- Assessing to what extent each system fulfils the following criteria:
- enables world-wide clinical trials to enter patient data electronically
- automatically corrects and generates forms
- facilitates the creation of new clinical trials in-house
- reduces costs by catching errors at source, eliminating the data entry step and
- reducing review requirements
- Assessing the reliability and security of these technologies
- Selecting the right technology for your organisation
Andy Richardson
Director of Information Systems
ClinTrials Research
Dr Andy Richardson trained in pharmacology at Sunderland and
Leicester before joining Merck Sharp & Dhome , where he held various scientific
positions. He left MSD in 1990 to join Quintiles European data management operation, where
he held senior data management positions until July 1996, when he joined ClinTrials
Research to take up his current position of Director, Information Systems,
Europe.
10:30 Developing training and management skills as a clinical data
manager
- Identifying and analysing key training needs for clinical data managers
- Ensuring personal development in response to new technologies
- Setting-up a successful training programme
- Working effectively with statisticians and your clinical colleagues
- Influencing decision makers for improvements in processes and procedures
Caroline Smith
Skills Development Advisor
Zeneca Pharmaceuticals
After obtaining an MSc in Statistics at the University of Newcastle upon Tyne,
Caroline Smith joined Zeneca Pharmaceuticals in 1986 as Statistician,
becoming a Biometrics Team Leader in 1993. Up to 1993, she worked mainly in the
Anti-infectives area and chaired the PSI Working Party on Anti-infectives before leading
the Phase I Biometrics team. Since September 1997, she has been working in data
management, responsible for leading a global project to revise training of data management
staff within Zeneca.
11:10 Morning coffee
11:30 Translating the technical benefits of various
technologies into real business value
- Analysing your specific needs to choose between ‘in-house’ and
‘off-the-shelf’ packages
- Assessing the extent to which commercial applications can be customised to meet
your requirements
- Ensuring that pilot projects achieve their objectives and your organisation gains
the promised benefits
- Gaining senior management financial buy-in to invest in technology-based clinical
solutions
- Evaluating the extent to which the various technologies are being used in
pharmaceutical data management today
Peter Church
Director, Information Technology
MDS Harris
 Peter
Church is a network engineer with 8 years IT experience. Peter
has worked in the CRO industry for over five years in roles ranging from database and
network administrationthrough support management to his present position of Director of IT
for MDS Harris. In this present position he is primarily concerned with
selecting, developing, and implementing innovative technologies which bring real benefit
to the processes and therefore the clients of MDS Harris.
12:10 Ensuring security of data transmission through new
mediums to help guarantee regulatory approval
- Understanding the extent to which the ICH ESTRI rules on the secure transfer of
data to regulators can be applied to the transfer of data between investigator and sponsor
sites
- Examining the attitude of the European, US and Japanese authorities towards
electronic data transfer and how this might impact on the acceptance of your final
clinical report
- Understanding the regulator’s response to open (Internet) and closed
(Intranet) wide area network collected data
- Meeting current guidelines on data integrity, authentication, non-repudiation and
confidentiality
Dr Antonia Rana
Scientific Officer
Joint Research CentreEuropean Commission
 Antonia Rana
has worked at the Joint Research Centre of European Commission since
1991. Amongst other research interests, Dr Rana is working on the security aspects of
intranets exposed to the Internet, including anti-intrusion and access control techniques
as well as the application of contemporary cryptology to computer-network communication.
Since 1995 she has been a member of the ICH M2 Expert Working Group, representing the European
Commission as a technical expert. Dr Rana was responsible for
the key management and certification structure of the ICH 3 ESTRI experiment in 1996,
involving the exchange of structured and non-structured information among the regulatory
authorities and pharmaceutical industry associations within the three ICH regions, and WAS
scientific co-ordinator during the deployment phase of the Eudranet (European Union Drug
Regulatory Netwok).
12:50 Lunch
Technology Case Studies
Chair: John Alexander Deputy Director, Research Support &
Information Systems
Roche Biosciences USA
14:00 Case study: Evaluating the impact of remote data entry (RDE) on
the quality of data and development cycle times
- Identifying which size and complexity of study will most benefit from RDE and
undertaking a cost/benefit analysis of switching from paper to electronic CRFs
- Ensuring adequate system and training support to build acceptance of RDE with
clinical teams, field monitors and investigators
- Comparing the benefits and pitfalls of investigators-based RDE, monitor-based RDE
and in-house staff entry on data quality, timeliness and data clean-up efforts
- Maximising the efficiency of your trials by using interim data as a tool for
trial management
- Ascertaining the regulatory status of clinical data collected through RDE
Andy Smith
Commercial Director
Remote Data Entry Ltd
 Andy
Smith is a founder and the commercial director of Remote Data Entry Ltd
a company that specialises in internet-based remote data entry services. Prior to
RDE, Andy was the Managing Director of AI International, a systems
integrator and leading distributor of computer software for the pharmaceutical and other
vertical markets. Andy has extensive first-hand experience of the
application of computer technology and concomitant process change within clinical
research. Particular emphasis has been placed on the adoption of new technology by
investigator staff to facilitate enhanced communication with monitors.
14:40 Case study: Assessing the potential uses for the Internet
technology in clinical data management
- Defining the terms Internet, Intranet and Extranet with reference to data
management
- Assessing the efficiency and ease of use of web technology as an interface
between diverse data management systems
- Addressing the security and confidentiality issues raised by the use of Internet
and Intranet technology
- Examining our practical experience of using the Intranet to provide daily updates
of project status
Dr Charles Kent
Lead Data Manager
Pfizer Central Research
After obtaining a PhD in Radiation Biology from the University of Cape Town in
1991, Dr Charles Kent went on to do a post-doc at the Institute of Cancer
Research in London. He then moved to Pfizer Central Research in 1995 as a
clinical data manager in phase II cardiovascular studies. In 1997, Dr Kent
was appointed lead data manager or phase III cardiovascular projects.
Regulatory Considerations for Data
Management
15:20 Afternoon Tea
15:40 Assessing the impact of the
European Data Privacy Directive on the processing of pharmaceutical research data
- Defining the terms (e.g. personal data) used in the Directive and other related
legal and regulatory guidelines
- Understanding the objectives of the Directive versus current legislation and
practice
- Considering the impact of the Directive regarding transborder data flow and
secondary data use in pharmaceutical research activities
- Reviewing the key elements and safeguards outlined in the draft EFPIA Code of
Conduct for the Pharmaceutical Industry on the Processing of personal data
Dr Stuart Cummings
Director, Clinical Biostatistics & Research Data Systems
Merck Sharpe & Dohme (Europe) Inc, Belgium
Dr Cummings joined Merck in Belgium in 1980 as a
medical statistician. In 1987 he was named director of Merck’s
European Biostatistics and Data Management Group with responsibility for providing support
for selected research studies and all international post-marketing trials to support local
registration, pricing and reimbursement. Between 1987 and 1993 he was involved in
developing and supporting Merck’s international distributed clinical
systems for phase III and IV clinical programmes. Dr Cummings is a member
of the DIA steering committee for Europe with responsibility for data and document
management issues, and is a former chairman of the Association for Clinical Data
Management. He is also co-chair of the EFPIA Working Party charged with developing the
European Industry Code of Conduct in response to the European Data Protection Directive. |
16:20 Successfully reconciling your databases for drug safety and
biometrics
- Assessing the new ICH guidelines for adverse event reporting and how they impact
on clinical data management
- Successfully re-engineering your adverse event reporting to efficiently manage
the information generated
- Co-ordinating the drug safety and clinical data management functions to reduce
duplication and produce compatible data for the regulators
- Ensuring the responsibility for safety reporting is clearly established between
investigator, sponsor and CRO
Michel Hucher
Head of Biometry Department
Institut de Recherche Pierre Fabre
 Michel
Hucher has been Head of Biometrics Department of Laboratoire Pierre Fabre
since November 1996. He previously worked at Roussel-Uclaf, now part of Hoechst Maroin
Roussel, for 15 years, first as a statistician and then as Head of the Biometrics
Department. Michel Hucher graduated from Ecole Polytechnique in Paris and
is also M.D.
17:00 Closing remarks from the Chair
17:10 End of day two
To
register call +44 (0) 171 915 5055 or send an Email |
|
|
