A CUSTOMIZED ORGANISATION FOR REAL FULL-SERVICE
ICTA offers a full-service which calls for the skills of real specific departments, each of them having the expertise to deliver an exhaustive service in their respecitve field of activity.
A PROVEN FULL-SERVICE
Centralized at the headquarters, ICTA's departments reap the benefit from a systemic organisation which favours a cross-departmental collaboration combining strength of proposal and operational expertise.
The synergy of this two-sided approach generates a very mature provision of services where the architecture of ICTA's organisation fully serves the design of the study and its objectives.
ICTA's full service covers the full management of any development plan, interventional or non-interventional clinical study, and includes the following services:
- R&D Consultancy
- Development plan
- Design of protocols, CRFs and questionnaires
- Targeting of countries, Key Opinion Leaders and participating centers
- Feasibility studies
- Management of investigational networks
- Management of regulatory affairs
- Logistics management of studies
- Development of e-CRFs, IWRS
- Operational on site and remote monitoring
- Clinical Study Technician activity
- Pharmacovigilance
- Data management
- Traditional and advanced biostatistics, modeling (Data mining, Bayesian network, neural analyses)
- Medical writing (clinical report, abstracts, publications)
- Management of contracts and fees
- Aid to decision making
If necessary, ICTA offers to its clients a comprehensive range of "à la carte" services.
Full-service and à la carte services are made available within a wide range of studies including:
- Feasibility studies
- Translational studies
- Exploratory studies of phases I, IIa and IIb (classical or adaptive frequentist or Bayesian studies)
- Confirmatory studies of phases IIb, III, (classical pivotal studies, seamless studies)
- Post-marketing phase IV studies
- Observational studies and registries
- Pharmaco-epidemiological studies (classical and Bayesian)
- ATU (French Temporary Authorisation for Use)
- RTU (French Temporary Recommandations for Use)
- Risk management plans
- «Rescue studies»