Presentation is loading. Please wait.

Presentation is loading. Please wait.

DGHO Studien Life is too short for long procedures.

Published byMarissa McCormick Modified over 10 years ago

Similar presentations

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 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 WINHO 2007 300.000 - 600.000 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 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 Colon Ca. Registry:09/061351 pat. Development

48 Colon Ca. Registry:09/061351 pat. Mamma Ca. Registry: 04/07365 pat. Development

49 Colon Ca. Registry:09/061351 pat. Mamma Ca. Registry: 04/07365 pat. RCC Registry: 11/07100 centres Development

50 Colon Ca. Registry:09/061351 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 !

Download ppt "DGHO Studien Life is too short for long procedures."

Similar presentations

Opera: presentation December, 10th 2009

Opera: presentation December, 10th 2009
$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200.

$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200.
$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300.

$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300.
$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500.

$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500.
ODM-based Study Archival Jozef Aerts XML4Pharma. History of the work February 2008: TMF asks to write an expert opinion (Gutachten) on the use of ODM.

ODM-based Study Archival Jozef Aerts XML4Pharma. History of the work February 2008: TMF asks to write an expert opinion (Gutachten) on the use of ODM.
1 US Investigator Meeting DIAS-4, Chicago, July 2011 Good Clinical Practice (GCP) for Investigators and the Research Team.

1 US Investigator Meeting DIAS-4, Chicago, July 2011 Good Clinical Practice (GCP) for Investigators and the Research Team.
$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300.

$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300.
European Cooperative Network for Research, Diagnosis and Therapy of Parkinson´s Disease EuroPa Plenary Meeting WORK PACKAGE 3 WORK PACKAGE 3 - Patient.

European Cooperative Network for Research, Diagnosis and Therapy of Parkinson´s Disease EuroPa Plenary Meeting WORK PACKAGE 3 WORK PACKAGE 3 - Patient.
16/06/2004 EuroPa Plenary Meeting -Paris -. 06.09.04EuroPa Plenary Meeting Paris Agenda EuroPa Plenary Meeting, Paris 9:00 - 9:15Meeting objectives /

16/06/2004 EuroPa Plenary Meeting -Paris EuroPa Plenary Meeting Paris Agenda EuroPa Plenary Meeting, Paris 9:00 - 9:15Meeting objectives /
$100 $400 $300$200$400 $200$100$100$400 $200$200$500 $500$300 $200$500 $100$300$100$300 $500$300$400$400$500.

$100 $400 $300$200$400 $200$100$100$400 $200$200$500 $500$300 $200$500 $100$300$100$300 $500$300$400$400$500.
FDA/Industry Workshop September, 19, 2003 Johnson & Johnson Pharmaceutical Research and Development L.L.C. 1 Uses and Abuses of (Adaptive) Randomization:

FDA/Industry Workshop September, 19, 2003 Johnson & Johnson Pharmaceutical Research and Development L.L.C. 1 Uses and Abuses of (Adaptive) Randomization:
Implementation of a Validated Statistical Computing Environment Presented by Jeff Schumack, Associate Director – Drug Development Information September.

Implementation of a Validated Statistical Computing Environment Presented by Jeff Schumack, Associate Director – Drug Development Information September.
Chapter 3: Utilization and Volume. 26 Chartbook 2000 Community hospital acute care admissions declined 15 percent between 1980 and 1994 and then began.

Chapter 3: Utilization and Volume. 26 Chartbook 2000 Community hospital acute care admissions declined 15 percent between 1980 and 1994 and then began.
1 National Center for the Training of Bank Personnel of Ukraine.

1 National Center for the Training of Bank Personnel of Ukraine.
ABTC Business Training & Consultancy 1 AZERBAIJAN BANK TRAINING CENTRE Knowledge path to successful business about ABTC July 01, 2008.

ABTC Business Training & Consultancy 1 AZERBAIJAN BANK TRAINING CENTRE Knowledge path to successful business about ABTC July 01, 2008.
EUROPEAN COMMISSION Social and economic cohesion OPEN DAYS 2006 The European Week of Regions and Cities Brussels, 9 – 12 October 2006 _________________________.

EUROPEAN COMMISSION Social and economic cohesion OPEN DAYS 2006 The European Week of Regions and Cities Brussels, 9 – 12 October 2006 _________________________.
The Managing Authority –Keystone of the Control System

The Managing Authority –Keystone of the Control System
European Union Cohesion Policy

European Union Cohesion Policy
200 300 400 500 Category 2 100 200 300 400 500 Category 3 100 200 300 400 500 Category 4 100 200 300 400 500 Category 5 100 200 300 400 500 100 Category.

Category Category Category Category Category.
$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300.

$100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300 $400 $500 $100 $200 $300.

Similar presentations

Ads by Google