FUNCTIONAL ANALYSIS OR IN OTHER WORDS « LOOKING AHEAD FOR CLOSER ACTION »
As a supporting pillar of ICTA's managerial approach, the Functional Analysis (FA) adapted to clinical R&D by our clinical operations department, is a methodology particularly suited to the management of clinical studies, whatever their complexity.
CONSISTENCY BETWEEN CLINICAL PROTOCOL AND MANAGERIAL SPECIFICATIONS
Functional Analysis logically leads to the design of a study protocol adapted to the medico-scientific objectives of the sponsor. This first step results in the design of functional specifications which reflect the managerial needs of the clinical protocol. FA also allows the identification of potential risks and the necessary means to be implemented for their management.
In this regard, ICTA’s management of the complexity includes risk-based management, a key component.
ICTA's MATRIX MANAGERIAL ORGANISATION
Each clinical study is steered by a project manager according to a matrix management mode. He is entirely responsible for all the different operational steps which have to satisfy the study requisites.
Thus, all departments that build up ICTA's full-service collaborate with the project manager who takes on full responsibility for the sequencing and the quality of their actions.
A STRONG AND CENTRALIZED MANAGEMENT
To satisfy the objectives entrusted to them and to maintain its course and its sustainability, ICTA has a strong and centralized management with a management committee responsible for ensuring the consistency and continuity of actions.
ICTA's ESPRIT DE CORPS
The Esprit de corps which can also be qualified as solidarity, is another hallmark of ICTA's project management. It stems from a successful common experience of clinical studies and development plan, and a dynamics where each participant is fully responsible for himself, but also for others.
POWERFUL IT ORGANISATION AND I-SIT PLATFORM
An IT platform (i-SIT) whose components were developed by the IT team in conjunction with the operational management teams, is made available to all study stakeholders via a secure web-based access portal, allowing amongst others the planning of objectives and monitoring of the projects in real time.
Just as pointed out by many audits conducted by our customers, the processing of information is for ICTA an instrument of functional cohesion of the company which is very efficient and has to be quoted as an example.
ISO-9001 CERTIFICATION IN INTERNATIONAL clinical R&D
ICTA's Functional Analysis of Needs is the foundation of ICTA's ISO-9001:2008 certification in international project management. This approach, which gave rise to a set of operating procedures acknowledged for their suitability and user-friendliness, is the foundation of a responsiveness recognized and appreciated by the whole of our audits.