Andrew Newbigging

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• Andrew Newbigging
• Managing Director

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Agenda

• Review of the past year
• New customers
• Vision and strategy
• Product development

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Introductions

• InferMed
• Andrew Newbigging
• Mark Snell
• Richard Meinesz
• Toby Aldridge
• Matthew Martin
• Ronald Schravendeel
• Martin Barnett

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Past year

• MACRO developments
• Archive Module for MACRO 3.0
• Package Deployment Utility
• API Web service
• Integration with randomisation server and IVRS
  (TENALEA)
• Security patches
• Performance patches
• Windows 2003 Oracle 10G support
• First implementation with Integrated Review

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Past year

• Customer support
• Quarterly patch
• Account management calls
• Almost all users upgraded to MACRO 3.0

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Past year

• Application Service Provider (ASP)
• First study live 120 patients from 20 sites so
  far
• Offline and online data entry available

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Past year

• Application Service Provider (ASP)
• MACRO hosted at InferMed for smaller studies
• MACRO decision support hosted at InferMed
  ORAMA project incorporates direct clinical advice
  to the investigator on most appropriate treatment
  of patients

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Past year

• 2004 was a profitable year for InferMed
• Follows period of losses due to investment in
  product development (i.e. MACRO 3.0)
• 2005 continuing profitable trend

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Past year

• Re-organisation at beginning of 2005
• Reasons Focus strategy

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New customers and users

• BOC Medical
• Chiltern
• INSERM, Paris
• KKS Muenster
• KKS Würzburg
• Medical Research Council
• Neurovascular Research Unit, Oxford
• Organon
• Parexel
• Quintiles
• Wales Cancer Trials Network
• University College London
• University of Liverpool (?)

• Novo Nordisk
• New eClinical Strategy
• Decided business case for EDC not proven
• Starting again
• InferMed and NNIT working together on joint
  proposal

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Customer services

• Account management calls
• Focus groups
• MOISD
• ARFG
• SAS
• Community website
• MACRO User Group
• Technical support service
• Satisfaction survey

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Vision

• Clinical research data from any source,
  collected once by compliant systems

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Strategy

• Product strategy
• Focus on ease of use usability for all users
  Investigators study nurses, monitors, data
  managers, study designers and administrators

• Technology strategy
• Migrate to .Net environment
• Reduce administrative overhead
• Introduce support for non-Microsoft clients

• Services strategy
• Core services are installation, training,
  maintenance and support, development
• Will partner for global services (hosting and
  help desk)

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Data collection trends
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Paper data collection

• Paper will be around for a long time
• MACRO is already used for data entry from paper
• Double data entry
• MACRO 3.2
• Q4, 2005
• Will be basis for .Net development of new Data
  Entry module

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Clinical data management

• Some customers have existing CDM (eg. Oracle
  Clinical)
• Clinical Gateway for Oracle Clinical 4.5

• Some customers use MACRO as a CDM system
• Clinical Coding (MedDRA) Q4, 2005
• SAS Focus Group

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Electronic data capture

• Will continue to support online and offline
• Package Deployment Utility
• Q2, 2005
• Automatic administration of offline sites
• Randomisation and IVRS
• Integration of TENALEA

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ePRO

• electronic Patient Reported Outcomes
• Patient diaries
• Quality of Life questionnaires
• Alpha release demonstrated today
• ePRO designer integrated into MACRO
• Patient enters data on PDA or tablet
• Wireless transfer of data back to MACRO
• New MACRO screens for ePRO data

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Direct Data Capture

• DDC electronic transfer of data into MACRO from
  other systems (e.g. hospital patient records,
  imaging) and devices
• Collaboration with
• Integration with Siemens patient record (Soarian)
  and interface engine (OpenLink) data
  automatically extracted from Soarian and
  transferrred to MACRO
• Integration with Siemens imaging systems
  consolidated views of CRF and image data
• Integration of MACRO into a single-sign on
  environment automatic user account creation,
  synchronised passwords
• Contact gudrun.zahlmann_at_siemens.com

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Technology strategy
Future
Now
Client
Server
Database
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Technology strategy
Future
Now
Client
APIs web services
Server
Archive
Batch modules
ePRO
Double data entry -------------- Data entry /
review
Study definition
System management
Database
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Summary

• Profitable, growing company
• Continuing to develop MACRO
• Extending services through partnerships
• Vision for clinical research
• Strategy
• Product
• Technology
• Services

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Thank you