Choose the best clinical strategy with the help of our seasoned clinical drug development experts.…
Clinical development
Choose the best clinical strategy with the help of our seasoned clinical drug development experts.
Regardless of the size of your company, the nature of your product or your needs, the streamlined approach of our medical and scientific experts and our biostatisticians will provide you with an analysis and key elements for the successful planning and design of your clinical projects.
A WIDE RANGE OF EXPERTISE
ICTA acknowledges the importance of a strategic analysis and decision-making process in drug and medical device development.
From scientific advice and recommendations to define the best strategic direction to drive your product to success, to a collaborative approach to help your team implement the most appropriate strategy, our Medical & Scientific affairs department has a proven track record in advising sponsors in a wide range of fields, at all stages of the product development cycle, and when developing comprehensive clinical development plans.
Our expertise is to provide realistic product development planning & study design
We deliver
- Gap analysis & study methodology
- Regulatory strategy (guidance for country selection)
- Support in discussions with regulatory authorities on development plans and trial design and/or results
- Clinical development from early to late phase clinical trials including traditional and adaptive/Bayesian approaches
- Real World Evidence & data generation from primary data collection to secondary data use
- Pharmacoeconomic modeling and analysis
- Clinical outcome assessments (including choice of relevant PROs & ClinROs)
- A wide range of medical writing services (protocol, CRF, Clinical study report, abstract/poster/article)
BASED ON BIOSTATISTICS & DATA SCIENCE EXPERTISE
- Objective/endpoint analysis
- Sample size estimation & justification
- Advanced statistical methodologies (Bayesian statistics, Generalized Linear Mixed Models, Multistate modelling, Latent Variable Modelling, …)
- Data mining and Artificial Intelligence to explore Real World Data
FOR A LARGE RANGE OF HEALTH PRODUCTS
- Drugs, medical devices, in-vitro diagnostics, health procedures
- Algorithms and connected objects, telemedicine / telemonitoring
OTHER AREAS OF EXPERTISE
Early access
ICTA set up a department dedicated to the conduct of Early Access and Compassionate Use…
Real World Evidence
With a large experience in health data assessments, ICTA teams are able to define the…
Health data analysis
Today we have access to increasingly large data sources. Advanced technologies surch as Artificial Intelligence…
Medical device
Experienced in the regulatory requirements for clinical investigations of medical and in-vitro diagnostic devices, we…
Decentralised studies
Our three-fold expertise in the regulatory, digital, and logistics fields makes ICTA a partner of…
