Project management

A strong and centralised project management organisation supported by a robust IT platform.

Centralised at ICTA’s headquarters, our organisation is fuelled by an active cross-functional collaboration, combining a creative source of propositions and operational expertise.

The synergy of this double approach generates a highly mature service delivery where the architecture of ICTA’s organisation fully serves the study design and its objectives.

A PROJECT MANAGEMENT ORGANISATION

where each project is assigned to an experienced project manager, who is supported by a dedicated multidisciplinary project team using a matrix management model.

ICTA’s skills are based on robust and centralised project management supported by:

A project management organisation based on ISO standards and certified by an ISO-certification 9001-2015 in “Management and development of national and international projects in clinical research” acknowledged by client audits

A core team of qualified clinical research assistants (CRAs) and clinical technician assistants (CTAs) who assist the project manager in daily activities and reporting

A regular oversight of the Project Managers’ activities by a Management Committee to ensure consistency and continuity of actions

THE ICTA PROJECT MANAGER, KEY point of CONTACT for THE SPONSOR

Our project managers, key points of contact for sponsors, are responsible for organising and overseeing the project throughout its development to meet the requirements of the study. Thanks to our specific IT tools and i-TMS®, project managers are constantly informed of the activities carried out (documentation, follow-up, patient inclusion, eCRF completion, etc…) and can implement risk management at project and/or site level. Project management activities are thus adapted to the needs of the project. Project progress is shared with sponsors and authorised project team members via the i-Report® allowing close, transparent and continuous communication.

OUR FULL-SERVICE OFFERING

ICTA’s clinical operations cover the full management of any development plan, interventional or non-interventional clinical study, real world evidence (RWE) programs, early access and compassionate use programs, and include the following services :

R&D Consulting
Development plan
Design of protocols, CRFs and questionnaires
Selection of countries, Key Opinion Leaders and participating centers
Aid to decision making
Feasibility studies
Management of investigational networks
Management of regulatory affairs
Management of contracts and fees
Management of study logistics

Development of integrated secure IT tools (e-CRFs, e-PROs, IWRS)
On-site, remote and centralized monitoring
Clinical Study Technician activity
Pharmacovigilance / Materiovigilance
Data management
Traditional and advanced biostatistics, modelling (Data mining, Bayesian network, neural analysis)
Medical writing (clinical report, abstracts, publications)

OUR FIELDS OF EXPERTISE

We provide full-service programs or customized services, regardless of the type of project:

Feasibility studies
Translational studies
Exploratory phase I, IIa and IIb studies (classical or adaptive frequentist or Bayesian studies)
Confirmatory phase IIb, III studies (classical pivotal studies, seamless studies)
Non Interventional studies and registries
Real World Evidence generation

Pharmacoepidemiological studies
Secondary data use studies
Early Access Programs
Compassionate Use Programs
Risk management plans
“Rescue” studies
Decentralised studies
Patient-centered studies

Project management

A PROJECT MANAGEMENT ORGANISATION

THE ICTA PROJECT MANAGER, KEY point of CONTACT for THE SPONSOR

OUR FULL-SERVICE OFFERING

OUR FIELDS OF EXPERTISE

Other services

Design

Regulatory affairs

Project management

Site Support

Risk-based monitoring

Vigilance

Data management

Biostatistics

Medical writing