ICTA’s IT, a time-tested IT expertise 

Since the start, ICTA's expertise and the quality of its services have encouraged its major clients to entrust the company with their clinical studies, often complex and pivotal, more often than not European ones and requiring the actual management of multinational investigation networks.

Hence ICTA had to acquire a whole range of IT tools capable of managing each project whatever the difficulty may be. 

I-SIT, A LOGICAL BICEPHALOUS CREATION

All the modules of ICTA's managerial and IT systems have been developed on the basis of a close collaboration between our IT department and our operational teams so as to make it an organisational platform adapted to the optimisation of our management and monitoring activities.  

In accordance with the regulatory requirements of 21CFR Part 11, I-SIT collaborative platform (ICTA Secure Information Technology) presents a core backbone which is easily customizable in order to meet the requirements of any clinical project whatever. 

IT Platform V2 EN

I-SIT, the COLLABORATIVE PLATFORM which delivers organized information in real time

  • I-SIT accounts for 6 complementary modules that can manage specifically each type of project (clinical studies of phases I to III, post-marketing studies, ATU, RTU, etc) whatever the international scope.
  • I-SIT integrates in each projet all the steps of ICTA's full-service (follow-up of regulatory affairs, monitoring of centres activities, inclusion and monitoring of patients, management of drugs, study-related documentation and monitoring activities, monitoring of SAEs, data management, etc) and provides to the decision maker and to the operational staff in real time, a "snapshot" of the progress of the project in the form of operational charts powered by the data flow released by ongoing studies.
  • I-SIT gives access to project stakeholders in real time to quality and performance metrics which trigger alerts when criticality thresholds are crossed, resulting in the implementation of corrective actions where they are needed. 

I-SIT's userfriendliness and ergonomic structure allow a comprehensive and quick analysis of the data. I-SIT provides in real time targeted and hierarchical information which reflects the progress and the consistency of the study allowing thus to spot the flaws if any.

I-SIT 8 modules

Web-based, mobile applications, whatever the medium 

Schema ISIT ENPoints Forts I SIT EN

Technologies and methodologies applied

Agile
Microsoft SQL Server
UML
.Net technologies (ASP.Net, C#)
Microsoft Sharepoint

Validation of computerized Systems according to GCP/ICH

GAMP5
21 CFR Part 11
Guide ACDM/SSI
PICS