A system for the planning and follow-up
management of clinical trials. It combines
3 key functionalities:
EDC (Electronic Data Capture)
- direct electronic capture of source data
eCRF (Electronic Case Report Form)
- transcription of source data into
EHR (Electronic Health Records)
ISKO modular architecture
- screening examination
- outpatient visits
- study exit examination.
- drug administration
- blood sampling and processing
- vital signs checks
- food intake
- water intake
- adverse events evidence
eTMF is a trial master file in electronic format. It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for clinical trials.
Our eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content including archiving, security and access control, change controls, audit trails, and system validation.
We offer a solution for both the sponsor and the CRO, which provides a unique possibility of remote study monitoring.
This module deals with the problem of data integrity in clinical trials. The module is designed in such a way so that it enables the sponsor to monitor the study online while maintaining the working comfort of a relevant CRO and the confidentiality of particular data and at the same time it assures the sponsor and the possible audit that the key data are not manipulated in any way. As such it contributes to the confidentiality of the whole study and CRO.
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