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Turn on more accessible mode. Turn off more accessible mode. Skip to main content. ClinConcept supports Pharmaceutical Companies, Biotechs and CROs with adopting new technologies and processes for Clinical Trials in the area of. 160;(Risk based Monitoring),. We help our customers to clearly define and document requirements, find the right modality for their specific protocol, select and manage technology vendors and project manage the technology part of their trial.

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Turn on more accessible mode. Turn off more accessible mode. Skip to main content. ClinConcept supports Pharmaceutical Companies, Biotechs and CROs with adopting new technologies and processes for Clinical Trials in the area of. 160;(Risk based Monitoring),. We help our customers to clearly define and document requirements, find the right modality for their specific protocol, select and manage technology vendors and project manage the technology part of their trial.
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Homepage | clinconcept.com Reviews

https://clinconcept.com

Turn on more accessible mode. Turn off more accessible mode. Skip to main content. ClinConcept supports Pharmaceutical Companies, Biotechs and CROs with adopting new technologies and processes for Clinical Trials in the area of. 160;(Risk based Monitoring),. We help our customers to clearly define and document requirements, find the right modality for their specific protocol, select and manage technology vendors and project manage the technology part of their trial.

INTERNAL PAGES

clinconcept.com clinconcept.com
1

ePRO / eCOA

http://www.clinconcept.com/Seiten/ePRO---eCOA.aspx

Patient Reported Outcomes ( PRO. Observer Reported Outcomes ( ObsRO. And Clinician Reported Outcomes ( ClinRO. Are today summarized under Clinical Outcomes Assessments (. In December 2009 the FDA released a. Guidance for the Industry. F a patient diary or some other f. While this is easy to document in the controlled environment of a clinic visit it strongly favors the use of electronic systems for any form of take home diaries (unsupervised data entry). . There are different ways to electronically colle...

2

EDC

http://www.clinconcept.com/edc

There is currently a new wave of discussions around this topic, mostly triggered by the. FDA Guideline about Risk based Monitoring. If you are considering Risk based Monitoring, we can help you to. Optimize your CRF design to improve data quality upon entry (it is much more effective to avoid errors than finding and fixing them downstream). Adjust your SOPs to implement a workflow of continuous quality control and adjustment.

3

Data Standards

http://www.clinconcept.com/data-standards

The Clinical Data Interchange Consortium ( CDISC. To develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The FDA has embraced and supported the vision of CDISC by making SDTM and ADaM a required format for electronic submissions following the eCTD standards. C) ClinConcept Euskirchener Strasse 37 - 53121 Bonn  Tel.: 49 228 9783786 info@clinconcept.com.

4

ePRO / eCOA

http://www.clinconcept.com/epro-ecoa

Patient Reported Outcomes ( PRO. Observer Reported Outcomes ( ObsRO. And Clinician Reported Outcomes ( ClinRO. Are today summarized under Clinical Outcomes Assessments (. In December 2009 the FDA released a. Guidance for the Industry. F a patient diary or some other f. While this is easy to document in the controlled environment of a clinic visit it strongly favors the use of electronic systems for any form of take home diaries (unsupervised data entry). . There are different ways to electronically colle...

5

Document Management

http://www.clinconcept.com/Seiten/Document-Management.aspx

We can help you. Our partner Turpin Vision has created a professional collaborative word processing tool that allows you to jointly develop and manage documents with external partners while keeping your sensitive program information confidential.  . For more information please refer to the. C) ClinConcept Euskirchener Strasse 37 - 53121 Bonn  Tel.: 49 228 9783786 info@clinconcept.com.

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Turn on more accessible mode. Turn off more accessible mode. Skip to main content. ClinConcept supports Pharmaceutical Companies, Biotechs and CROs with adopting new technologies and processes for Clinical Trials in the area of. 160;(Risk based Monitoring),. We help our customers to clearly define and document requirements, find the right modality for their specific protocol, select and manage technology vendors and project manage the technology part of their trial.

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