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EDC Case Studies Read about how Explore Consulting has helped Seattle biotechnology companies implement Electronic Data Capture systems for clinical trials and comply with regulations by auditing vendors. |
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FDA Guidance on Clinical Systems |
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| Clinical Data Management Systems (CDMS) The Explore team implements Clinical Data Management Systems (CDMS) such as Clintrial sold by Phase Forward. We audit the vendor system development life cycle and validate installations for clients that have different ways of processing clinical trial data. In addition to supporting system implementation, Explore Consulting integrates Clintrial with a variety of other applications that support clinical operations. For example, we integrate a Case Report Form (CRF) imaging and workflow application (CRF WorkManager sold by Integic) by working closely with vendor product development technicians. We integrate sponsor-developed Clinical Trial Management Systems (CTMS) to automatically enroll patients in Clintrial. We integrate Clintrial data tables into data warehouses for clinical operations dashboards.
To find out more about how Explore Consulting can help, contact us. |
Beyond
integration, Explore Consulting even replaces the Clintrial interface
to the underlying Oracle database. When a client needed to retire
Clintrial and archive clinical data stored in the system, Explore
Consulting created a dynamic user interface for the Clintrial database
tables. This solution eliminated Clintrial maintenance costs while
retaining controlled, audit trail enabled access to archived data.