17th February 2011, Hanover. Elisabeth Finger Ronald Severin

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1 C l i n i c a l T r i a l D o c u m e n t a t i o n C h a l l e n g e 17th February 2011, Hanover Elisabeth Finger Ronald Severin

2 Quadratek Data Solutions Ltd. Formed in 2004 Part of Quadratek, formed 1997 Quadratek Data Solutions Ltd. is headquartered in the UK with office in Berlin, Germany Specializes in development of eclinical solutions & associated Services Provides support, implementation and hosting for Pharmaceutical companies and CROs Clincase: o Fully featured EDC solution with CDM functionalities o Open architecture, based on industry standards o Fully compliant with FDA 21 CFR part 11 o Suitable for all types and phases of clinical trials and noninterventional trials 2

3 Clincase System Modules Clincase WORKBENCH RICH CLIENT (DDE) WEB CLIENT (RDE) - Online Desktop Application - Online data entry - Zero-Footprint client - Drag & drop environment and monitoring - Supports all common - Study Design & DM - Easy to install, web browsers - Deployment & Administration automated updates - No plug-ins required - Customizable interface for - User experience similar - On-page data different screen resolutions to Web Client validation - Extendable through custom - Easy to switch between - Superior performance plug-ins online and offline and user experience - Various data views for all - Supports read-only offline stages of trial implementation copies for archiving - Automated updates - Superior performance and user experience 3

4 Allgemeine Angaben zu clincase Frage Frage Frage Export-Schnittstellen Unterstützung von Standards aus der KIS/KAS-Welt Unterstützt CDISC-Standards Bildimport Importschnittstellen (z.b. für Labordaten) Schnittstelle zum SAE-Management bzw. Safety-Datenbank Wiederverwendbarkeit von: SAS XML ASCII HL 7 DICOM xdt Ja, ODM und SDTM Ja, Upload und Review Ja, ASCII- und CDISC-Labordaten Ja, esae als PDF E2B-Standardformat (in Bearbeitung) CRF-Seiten CRF-Teilseiten Checks Variablenformate Auch zwischen RDE und DDE? Ja Nein Frage Datenbank-Backend Oracle MySQL SQL Server PostgreSQL SAS Data Set Andere, 4

5 CRF-Design WORKBENCH Metadata Layout Editor with Toolbar Properties Release and Deployment of Metadata Form preview 5

6 Print functions: Generating reports WEB CLIENT / RICH CLIENT Blank CRF page 6

7 Print functions: Generating reports Completed CRF page Annotated CRF page 7

8 Data entry WEB CLIENT (RDE) Log in /Sign out Annotations Navigation Buttons Outline Panel Quick Search Actions 8

9 Data entry WEB CLIENT (RDE) Future dates 9

10 Data entry WEB CLIENT (RDE) Stop date before end date 10

11 Data entry WEB CLIENT (RDE) Start date missing 11

12 Data entry WEB CLIENT (RDE) Partial dates Comment function 12

13 Data entry WEB CLIENT (RDE) End date as unknown 13

14 Data entry WEB CLIENT (RDE) Serious adverse events (SAEs) SAE management in Clincase: Notification by to PV with individual text: automatic or with permission SAE details automatically filled in PDF SAE form Send by or print and send by fax E2B standard format for esaes will be implemented 14

15 Data entry RICH CLIENT (DDE) Query Annotations Path Outline Panel Quick Search Actions 15

16 Data entry 1st pass (RICH CLIENT) 16

17 Data entry 2nd pass (RICH CLIENT) 17

18 Verification of the AE page (DDE) 18

19 Auto-Queries 19

20 Manual Queries 20

21 Medical Coding and Audit Trial Medical Coding 1st version with WHO DD support will be presented end of March 2011 MedDRA support planned after WHO DD implementation Audit Trail 21

22 Medical Coding and Audit Trial Item Description of the adverse event Item End date 22

23 License models 1. Application Service Provider model (ASP model) License per trial Monthly payment, terminates with end of trial 2. In-house model Lifetime license Single payment for the software / annual maintenance fees Additional Services Helpdesk Data Hosting Training 23

24 Contact Quadratek Data Solutions Ltd. Berlin Office: Albrechtstrasse Berlin, Germany Phone: +49 (0) UK Office: Winchfield Lodge Old Potbridge Road Winchfield Hampshire RG27 8BT Phone: +44 (0) Internet: 24

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