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 !