Risk_Management EN

The monitoring of clinical risk by Systemic Analysis

ICTA has been encompassing the management of risk in a quality approach driven by Systemic Analysis, and in particular Functional Analysis to validate the constraints of requirements and costs.

Thus, ICTA dissects the clinical studies that it manages in order to identify potential risks at all stages of their development and propose solutions to understand them better.

A great tool called "ICTA Value Management System" or IVMS

This approach was then formalized to be framed in a responsiveness proactivity quality approach
At the initiation of each project, the whole project team conducts a risk analysis and leverages its cross-departmental expertise to better analyze and prioritize risks regardless of the level of development of a clinical study. An action plan to prevent these risks is then developed, the means necessary to the implementation of the solutions adopted are integrated in the Functional Specifications with the aim to build an organization that suits the goals to achieve.

ICTA’s full-service combined with its organizational functioning guarantee proactive risk management. They provide ICTA’s project leaders with all the necessary control levers to ensure that all steps taken are in line with the needs of the study.

2010, I-SIT Collaborative Platform and its eReport module

These means of control are particularly strengthened since ICTA has developed in-house, and according to the requirements of 21 CFR Part 11, I-SIT (ICTA Secure Information Technology), a set of computer tools based on a platform of collaborative work facilitating the sharing of documents and information in real time via a secure portal accessible to all the target actors of the project.

I-SIS includes a reporting module, i-Report, which provides ICTA’s project leaders with dashboards that summarize projects-related key indicators. These indicators aim at alerting the project leader of any drift of the project. These indicators coupled to the information collected in real time via i-SIS and relayed by our field Clinical Research Assistants are as much feedback which enables ICTA’s project manager to take the necessary corrective measures, whatever the level of risk assessed.

A top-of-the-range monitoring trained to IVMS requirements.

Our risk management policy also operates on the field, since ICTA has been practising for many years "adaptive monitoring" in order to concentrate its monitoring activity on the centers which have the greatest need. To this end, and with a view to best manage the potential risks, our project managers assess repetitively the needs of the centers and organize, and adapt when necessary, the visits of the CRAs to concentrate on the most sensitive centers. This assessment allows the project team to have a real-time monitoring of the centers and of the patient data and therefore of the crossover quality markers between the monitoring activities and data management activities. 

Finally, the e-CRFs developed in-house by ICTA and interfaced with i-TMS via the I-SIS platform provide Source Data Verification and dynamic controls functionalities that allow an online control of clinical data.