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DGHO Studien Life is too short for long procedures.

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Presentation on theme: "DGHO Studien Life is too short for long procedures."— Presentation transcript:

1 DGHO Studien Life is too short for long procedures

2 iOMEDICO Network cooperation EDC/CTMS technology Cancer Registries iOMEDICO

3 Networks Partner of Scientific Networks DGHODt. Gesellschaft für Hämatologie & Onkologie (Clinicians + Outpatient cancer centres, ~ 2000) AIOArbeitsgemeinschaft Internistische Onkologie (Clinicians, ~ 1000) AKSArbeitskreis Klinische Studien (Outpatient cancer centres, ~ 250 ) CESARCentral European Society Anticancer Research (Clinicians, ~ 200)

4 Networks Partner of Scientific Networks DGHODt. Gesellschaft für Hämatologie & Onkologie (Clinicians + Outpatient cancer centres, ~ 2000) AIOArbeitsgemeinschaft Internistische Onkologie (Clinicians, ~ 1000) AKSArbeitskreis Klinische Studien (Outpatient cancer centres, ~ 100 ) CESARCentral European Society Anticancer Research (Clinicians, ~ 200)

5 AKS actually ~ 100 outpatient cancer centres ~ 200 medical oncologists about cancer patients/oncologist/year cancer patients/year

6 WINHO: Outpatient Cancer Centres 2007 actually ~ 350 centres ~ 700 medical oncologists about cancer patients/oncologist/year WINHO cancer patients/year

7 iOMEDICO structure iOMEDICO IT groupSMO TeamCRO Team

8 CRO team 18 employees currently 28 projects running in TA Oncology

9 IT team 15 employees service provider EDC and CTMS

10 SMO team 6 Site Manager (certified study nurses) assistants / study nurses of the investigational sites (contracted by the investigator)

11 Team around iOMEDICO Freelancer Site Managers2 Monitors3 Medical Writer2 Advisor Statistics3 Oncology12

12 Projects up to 1600 patients / clinical trial (phase III) up to 2500 patients / registry

13 Full Service Provider iostudy office project management monitoring site management data management statistics study report EDC (e-CRF) & CTMS

14 Network Site Manager Network of physicians

15 Electronic Data Capturing EDC

16 Design & Programming the software will be adapted to the protocol like a tailor-made suit programming and validation: 6 weeks from final protocol the system is ready for service: 7th week from commissioning EDC System iostudy office

17 Design & Programming the software will be adapted to the protocol like a tailor-made suit programming and validation: 6 weeks from final protocol the system is ready for service: 7th week from commissioning EDC System iostudy office

18 Documentation iostudy office

19 Plausibility checks iostudy office

20 Resulting Query iostudy office

21 Audit Trail iostudy office

22 FDA 21 CFR Part 11 compliant certified according to ISO 9001:2000 internal and external QM audits implemented completeness and plausibility checks query management audit trail systemic data checks cryptographic signatures Quality management EDC System iostudy office

23 Profile Efficacy ~ 50 % EDC System reliable and easy documentation preventive quality management (pausibility checks / queries) process transparency (fast track) iostudy office

24 Clinical Trial Management System CTMS

25 CTMS System Clinical Trial Management System e-CRF data collection correction quality management monitoring iostudy office

26 CTMS iostudy office CTMS System Clinical Trial Management System e-CRF data collection correction quality management monitoring …… project management project overview data management investigator payment …… iostudy office

27 direct access to data of the eCRF CTMS iostudy office

28 CTMS : Reports iostudy office

29 CTMS : Reports iostudy office

30 direct access to data of the eCRF transparency on all processes CTMS iostudy office

31 CTMS: Documents (Versioning) iostudy office

32 CTMS : Reports iostudy office

33 CTMS: Investigators payment iostudy office

34 direct access to data of the eCRF transparency on all processes connecting all persons involved CTMS iostudy office

35 Clinical research group network PMs CRA Controling IT SM Mon CL Partner AIO CESAR Investigator iostudy office AKS others DGHO iostudy office

36 Cancer Registries

37 Rationale documentation of colon cancer treatment in real life situation demonstration of strategies and therapeutic sequences in adjuvant and palliative treatment indication development of prognostic scores in adjuvant and palliative situation, correlation to comorbidity scores

38 Centres & patients 60 outpatient cancer centres in Germany patients

39 e-CRF Documentation demography decision making processes tumor profile comorbidity therapeutic decisions systemic therapies and sequences relevant side effects radiotherapy palliation processes

40 Sequences

41 Dosing details, side effects

42 Adjuvant III/06/-I/07

43 Palliative 1st-line III/06/-I/07

44 Dynamic pallitive

45 AE Bevacizumab, incidence

46 Recruitement 13 months > 100 pts./month

47 Colon Ca. Registry:09/ pat. Development

48 Colon Ca. Registry:09/ pat. Mamma Ca. Registry: 04/07365 pat. Development

49 Colon Ca. Registry:09/ pat. Mamma Ca. Registry: 04/07365 pat. RCC Registry: 11/07100 centres Development

50 Colon Ca. Registry:09/ pat. Mamma Ca. Registry: 04/07365 pat. RCC Registry: 11/07100 centres NHL Registry:Q2/08 Development

51 Cancer registries THEMA Co-operation projects

52 Herzlichen Dank !


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