DGHO Studien Life is too short for long procedures.
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Transcript of DGHO Studien Life is too short for long procedures.
DGHO Studien
Life is too short for long procedures
iOMEDICO
Network cooperation
EDC/CTMS technology
Cancer Registries
iOMEDICO
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)
CESARCentral European Society Anticancer Research(Clinicians, ~ 200)
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)
CESARCentral European Society Anticancer Research(Clinicians, ~ 200)
AKS
actually ~ 100 outpatient cancer centres
~ 200 medical oncologists
about 600 - 1000 cancer patients/oncologist/year
120.000 - 200.000 cancer patients/year
WINHO: Outpatient Cancer Centres 2007
actually ~ 350 centres
~ 700 medical oncologists
about 400 - 1000 cancer patients/oncologist/year
WINHO2007
300.000 - 600.000 cancer patients/year
iOMEDICO structure
iOMEDICO
IT group SMO Team CRO Team
CRO team
18 employees
currently 28 projects running in TA Oncology
IT team
15 employees
service provider EDC and CTMS
SMO team
6 Site Manager (certified study nurses)
assistants / study nurses of the investigational sites
(contracted by the investigator)
Team around iOMEDICO
Freelancer
Site Managers 2
Monitors 3
Medical Writer 2
Advisor
Statistics 3
Oncology 12
Projects
up to 1600 patients / clinical trial (phase III)
up to 2500 patients / registry
Full Service Provider
iostudy office
project management
monitoring
site management
data management
statistics
study report
EDC (e-CRF) & CTMS
Network
Site Manager
Network of physicians
Electronic Data CapturingEDC
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
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
Documentation iostudy office
Plausibility checks iostudy office
Resulting Query iostudy office
Audit Trail iostudy office
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
Profile
Efficacy ~ 50 %
EDC System
reliable and easy documentation
preventive quality management (pausibility checks / queries)
process transparency (fast track)
iostudy office
Clinical Trial Management SystemCTMS
CTMS System Clinical Trial Management System
e-CRF
data collection
correction
quality management
monitoring
iostudy office
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
direct access to data of the eCRF
CTMS iostudy office
CTMS : Reports iostudy office
CTMS : Reports iostudy office
direct access to data of the eCRF
transparency on all processes
CTMS iostudy office
CTMS: Documents (Versioning) iostudy office
CTMS : Reports iostudy office
CTMS: Investigator’s payment iostudy office
direct access to data of the eCRF
transparency on all processes
connecting all persons involved
CTMS iostudy office
Clinical research group network
PMsCRA
ControlingIT
SMMon
CL
Partner
AIOCESAR
Investigator
iostudy office
AKS others
DGHO
iostudy office
Cancer Registries
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
Centres & patients
60 outpatient cancer centres in Germany
2.500 patients
e-CRF Documentation
demography
decision making processes
tumor profile
comorbidity
therapeutic decisions
systemic therapies and sequences
relevant side effects
radiotherapy
palliation processes
Sequences
Dosing details, side effects
Adjuvant III/06/-I/07
Palliative 1st-line III/06/-I/07
Dynamic pallitive
AE Bevacizumab, incidence
Recruitement
13 months
> 100 pts./month
Colon Ca. Registry: 09/06 1351 pat.
Development
Colon Ca. Registry: 09/06 1351 pat.
Mamma Ca. Registry: 04/07 365 pat.
Development
Colon Ca. Registry: 09/06 1351 pat.
Mamma Ca. Registry: 04/07 365 pat.
RCC Registry: 11/07 100 centres
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
Development
Cancer registries
THEMA
Co-operation projects
Herzlichen Dank !
