Infer Med: True EDC for Oracle Clinical

1
Infer Med True EDC for Oracle Clinical

• OCUG
• September 2003

2
What Oracle Clinical Users Need

• True EDC functionality
• Two-way dataflow with OC backend
• A proven product with clinical history
• High site and internal user satisfaction
• Infer Med offers this NOW.

3
The Infer Med Solution

• A proven product with clinical history
• High site and internal user satisfaction
• MACRO
• True EDC functionality
• Clinical Gateway
• Two-way dataflow with OC backend

4
Seamless OC - EDC Integration

• Clinical Gateway from Infer Med is the only
  independent tool which seamlessly integrates
• Metadata
• Patient data
• OC-generated discrepancies
• with Oracle Clinical

5
The Proven Solution

• The Infer Med Solution is the only EDC solution
  integrated with Oracle Clinical which is proven
  clinically
• Used since 1999
• Over 60,000 patients from 35 countries
• Used in all Phases of drug development and
  postmarketing research

6
Infer Med The Proven Company

• Established in 1998
• Support staff in London, Boston Singapore
• Implementation support provided by Infer Med
  staff
• Providing advanced software solutions for
  investigators and healthcare organizations
• Innovative AREZZO technology providing
  intelligent clinical decision support

7
Why Infer Med Clinical Gateway?

• Get the benefits of true EDC now
• Because CG enables intimate integration with the
  way you work with Oracle Clinical now, it enables
  you to add EDC while
• Reducing study setup time
• Enforcing global study design standards by using
  the OC global library for EDC
• Simplifying and accelerating data transfer and
  closure

8
Clinical Gateway - MACRO EDC Workflow
9
Clinical Gateway Workflow

• Based on a study definition from Oracle Clinical,
  creates a study definition to be used by MACRO
• And, creates a Study Map to be used to translate
  data from MACRO to OC
• Clinical Gateway Server transfers MACRO study
  data into OC
• Discrepancies from OC are automatically
  transferred to MACRO at the site resulting
  clinical data changes flow back through CG to OC

10
Clinical Gateway Design Tool
CG displays your OC study as a hierarchy of CPEs,
DCIs, DCMs, Question Groups, Questions and DVGs
11
Clinical Gateway Design Tool / 2
CG shows the visits, eForms, questions and
category values in MACRO
12
Clinical Gateway Admin

• Clinical Gateway is invisible to most users in
  the Infer Med/OC solution.
• The CG Admin Tool used by the administrator
  provides
• Server status
• Mapping status
• Log of all link activity
• Remote link configuration

13
MACRO True EDC

• A best-in-class EDC tool
• Easy-to-use study definition
• Online or offline data entry at investigative
  sites
• Graphical navigation and workflow aids for sites
  and monitors
• Immediate and back-end discrepancy checks

14
A Best-in-Class Tool

• Full monitoring support features which
  computerize repetitive monitoring functions
• Trial status information on login
• Readily accessible Reports
• Batch Data Loader for lab data, diaries and data
  collected from other external devices or
  applications
• CDISC ODM compatibility
• Electronic signatures

15
Easy Study Definition

• A simple graphical design tool
• Data entry clerks can learn the tool in hours
• Customers rarely call the Help Desk with design
  tool questions

16
Online Offline Data Entry

• MACRO is one of the very few successful EDC tools
  on the market to offer true online and offline
  data entry options which enable-
• Maximum site flexibility
• Maximum study flexibility
• Maximum geographic flexibility

17
Study Status Information inReal Time

• A true EDC tool, MACRO provides trial status
  information in real time, so you can react
  immediately to problems and opportunities
• Recruitment rates
• Data quality
• Adverse events
• Unresolved discrepancies

18
Applicable throughout Drug Development

• MACRO has been used in all Phases, I-IV
• From single-site to large multinational studies
• Ideally suited for drug or disease registries and
  other post-marketing uses, unlike other EDC tools

19
MACRO / CG Benefits

• EDC system doesnt need to be configured
  separately
• Consistency between EDC and Oracle Clinical
• Automatic, real-time data transfer
• Combines best features of both worlds
• EDC for data validation on entry
• OC for batch data validation coding

20
MACRO Study Definition

• Design library employs easy to use Explorer-style
  hierarchy

21
MACRO Login

• Each users home page fully configurable
• Quick access to common tasks
• Can display dynamic reports

22
MACRO Subject Records

• Icons in visit schedule indicate at a glance
  status of eCRFs
• Discrepancies
• SDVs
• Warnings
• Locked/Frozen
• Missing data

23
Icon-Assisted Data Review

• Icons on each data field indicate lock status,
  discrepancy status, whether there is an
  investigator comment, and how many times the
  field data has been changed
• Users can work in split-screen mode, viewing the
  eCRF on top and SDV, discrepancy or audit trail
  information on the bottom

24
Repeating Question Groups

• MACRO fulfills one of the most requested EDC
  features repeating groups

25
Superior EDC Reports

• Many Reports are included in MACRO to allow users
  to view and print all aspects of the database.

26
Report Example / 1

• Validation rules report

27
Report Example / 2

• Subject Status summary report

28
MACRO Clinical GatewayTrue EDC for Oracle
Clinical

• Call Infer Med on 1 617 367 0010 to use a real
  EDC product now, that fully integrates with your
  CDMS.