Clinical Trial Software from A to X

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1 Clinical Trial Software from A to X XClinical GmbH, 2011

2 Participants from XClinical Dr. Philippe Verplancke CEO & Founder PhD, Electro-technical Engineer Previously: Management Consultant CTO epro vendor 12+ years experience in IT / healthcare projects 2

3 Facts & Figures Founded: 2002 Headquarters: Legal form: CEO: Main activity: Annual revenue: Munich / Germany GmbH, private ownership Dr. Philippe Verplancke Development of software for clinical trials 1,4 Mio. Euro Number of employees: 19 Products: MARVIN, STUDY COMPOSER 3

4 Global Provider of Software and Services for the Healthcare Industry Headquarters and Sales Offices Munich, Germany Paris, France Boston, USA Global Network of Certified Partners (a selection) USA BioStat IDDI Europe A-Pharma Hands-on Harrison Clinical Research GPOH IDDI ikfe IKKF Pharmalog HCTC Asia Asklep 4

5 Comprehensive Experience Proven Product Usage More than 100 trials running Over 93,000 subjects documented All kinds of trials 3 Phase IV 16 Phase III Registry, DMP PMS, NIS, Medical Product FU, Other Phase I-IV Phase II Phase I 5

6 Our Services Tech Transfer Training contains all the modules necessary to set up your trials independently with MARVIN Train the Trainer Training is aimed at preparing you to teach your investigators how to use MARVIN Support with the adoption of SOPs and workflows Advice on performing study-specific validations IT qualification of centers Project and communication management Assistance with the implementation of CDISC data standards Creation of the ecrfs incl. queries Creation of users, roles and access rights Creation of online reports and data export routines Customization of enhanced requirements like randomization, drug accountability and logistics, metadata and libraries Modification of the separate patient identification database Configuration of the laboratory data import Hardware and software setup Security Management Monitoring Backup Hot standby service 6

7 XClinical's Products Major CDISC standards in the eclinical process fully supported by our products 7

8 Fully Integrated, CDISC based Workflow ecrf Screens define.xml XML ODM auto - generate Query logic XLS DOC XML ODM SDTM Domains PDF Study Structure Description Annotated CRF DVP, etc. CDISC ODM Database proc_cdisc TTables 8

9 MARVIN Integrated eclinical Application MARVIN offers some unique features Multi-language capabilities, including Japanese character sets etc. Combination of EDC and DDE in the same study Patients as User feature to integrate web-based epro Clickable anatomic images Binary data integration Compliant & Certified 21 CFR Part 11 compliant ICH-GCP compliant CDISC ODM certified 9

10 Allgemeine Angaben zum System Frage Frage Frage Frage Export-Schnittstellen SAS 1 XML ASCII Unterstützung von Standards aus der KIS/KAS-Welt HL7 ² DICOM xdt ² Unterstützt CDISC Standards Bildimport Importschnittstellen (z.b. für Labordaten) Schnittstelle zum SAE-Management bzw. Safety- Datenbank Wiederverwendbarkeit von: Auch zwischen RDE und DDE Ja, ODM und SDTM und LAB Ja, beliebige Formate Ja, CDISC LAB und andere mittels ODM-Transformation Ja, XML-Dateiexport und Webservice Nein CRF Seiten CRF Teilseiten Checks Variablenformate Ja Nein Datenbank Backend Oracle ³ MySQL ³ SQL Server ³ PostgreSQL SAS Data Set ³ Andere ³ 1 via proccdisc; 2 via custom scripts; 3 jede JDBC-konforme Datenbank kann auf Anfrage validiert werden 11

11 Kostenbeispiel (kommerzielle Studie) Sponsor Laufzeit Dt. Krebshilfe 72 Monate Kosten / RDE Kosten / DDE Anzahl von Zentren 25 Patientenzahl 600 CRF insgesamt 77 > 100 T 12,5 T Unique CRF 16 Items pro Seite 40 Kosten pro Tag (support) 150,- / Std. 150,- / Std. Hosting bei Anbieter (6 Jahre) 36 T 18 T 12

12 Kostenbeispiel (kommerzielle Studie) Sponsor Laufzeit Dt. Krebshilfe 72 Monate Kosten / RDE Kosten / DDE Anzahl von Zentren 25 Patientenzahl 600 CRF insgesamt 77 > 100 T 12,5 T Unique CRF 16 Items pro Seite 40 Kosten pro Tag (support) 150,- / Std. 150,- / Std. Hosting bei Anbieter (6 Jahre) 36 T 18 T 13

13 Unique competitive advantages XClinical STUDY COMPOSER MARVIN 14

14 Clinical Trial Software from A to X XClinical GmbH Siegfriedstrasse Munich/Germany Tel: +49 (0)89 / Fax: +49 (0)89 / info@xclinical.com XClinical GmbH, 2011