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DGHO Studien Life is too short for long procedures

DGHO Studien Life is too short for long procedures. iOMEDICO. Network cooperation. iOMEDICO. EDC/CTMS technology. Cancer Registries. Networks. Partner of Scientific Networks DGHO Dt. Gesellschaft für Hämatologie & Onkologie (Clinicians + Outpatient cancer centres, ~ 2000)

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DGHO Studien Life is too short for long procedures

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  1. DGHO StudienLife is too short for long procedures

  2. iOMEDICO Network cooperation iOMEDICO EDC/CTMS technology Cancer Registries

  3. Networks • Partner of Scientific Networks • DGHO Dt. Gesellschaft für Hämatologie & Onkologie(Clinicians + Outpatient cancer centres, ~ 2000) • AIO Arbeitsgemeinschaft Internistische Onkologie(Clinicians, ~ 1000) • AKS Arbeitskreis Klinische Studien(Outpatient cancer centres, ~ 250) • CESAR Central European Society Anticancer Research(Clinicians, ~ 200)

  4. Networks • Partner of Scientific Networks • DGHO Dt. Gesellschaft für Hämatologie & Onkologie(Clinicians + Outpatient cancer centres, ~ 2000) • AIO Arbeitsgemeinschaft Internistische Onkologie(Clinicians, ~ 1000) • AKS Arbeitskreis Klinische Studien(Outpatient cancer centres, ~ 100) • CESAR Central European Society Anticancer Research(Clinicians, ~ 200)

  5. AKS • actually ~ 100 outpatient cancer centres • ~ 200 medical oncologists • about 600 - 1000 cancer patients/oncologist/year 120.000 - 200.000 cancer patients/year

  6. WINHO: Outpatient Cancer Centres 2007 • actually ~ 350 centres • ~ 700 medical oncologists • about 400 - 1000 cancer patients/oncologist/year 300.000 - 600.000 cancer patients/year WINHO2007

  7. iOMEDICO structure iOMEDICO IT group SMO Team CRO 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 Managers 2 • Monitors 3 • Medical Writer 2 • Advisor • Statistics 3 • Oncology 12

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

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

  14. Network of physicians Network Site Manager

  15. Electronic Data CapturingEDC

  16. iostudy office Design & Programming EDC System • 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

  17. iostudy office Design & Programming EDC System • 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

  18. iostudy office Documentation

  19. iostudy office Plausibilitychecks

  20. iostudy office ResultingQuery

  21. iostudy office AuditTrail

  22. iostudy office Quality management EDC System • 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

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

  24. Clinical Trial Management SystemCTMS

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

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

  27. iostudy office CTMS • direct access to data of the eCRF

  28. iostudy office CTMS : Reports

  29. iostudy office CTMS : Reports

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

  31. CTMS: Documents (Versioning) iostudy office

  32. iostudy office CTMS : Reports

  33. CTMS: Investigator’s payment iostudy office

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

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

  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 • 2.500 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. Development • Colon Ca. Registry: 09/06 1351 pat.

  48. Development • Colon Ca. Registry: 09/06 1351 pat. • Mamma Ca. Registry: 04/07 365 pat.

  49. Development • Colon Ca. Registry: 09/06 1351 pat. • Mamma Ca. Registry: 04/07 365 pat. • RCC Registry: 11/07 100 centres

  50. Development • Colon Ca. Registry: 09/06 1351 pat. • Mamma Ca. Registry: 04/07 365 pat. • RCC Registry: 11/07 100 centres • NHL Registry: Q2/08

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