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Systems for CROs

ISKO

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
    pre-defined forms

EHR (Electronic Health Records)

ISKO modular architecture

Outpatient modul

  • screening examination
  • outpatient visits
  • study exit examination.

Confinement modul

  • reception
  • check-in
  • drug administration
  • blood sampling and processing
  • vital signs checks
  • food intake
  • water intake
  • adverse events evidence
  • reporting

ISKO allows for automated generation of datasets for ICH E3 Final Report
Demography
Protocol deviations and violations – statistics and reporting
AE/SAE statistics and reporting
ISKO allows for integration of data within PK/PD evaluation
Study Planning and Schedule
Randomization, Demography, Sampling time deviations, Protocol Deviations
ISKO supports GCP R2 compliance of data management
Full audit trail – CFR 21 Part 11 compliant
Monitoring module, automatic query generation including their own audit trail

eTMF

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.

Sponsors module

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.

Contact Us

Let’s meet & grow

Management

Management

Petra Oertlová

Business Development Manager
T: +420 777 917 742
E: petra.oertlova@ndata.cz

Vladimír Hujer

Ing. Josef Richter

Head of Development
T: +420 607 614 794
E: josef.richter@ndata.cz