Choose the best clinical strategy with the help of our seasoned clinical drug development experts.…
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
- 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
FOR A LARGE RANGE OF HEALTH PRODUCTS
- Drugs, medical devices, in-vitro diagnostics, health procedures
- Algorithms and connected objects, telemedicine / telemonitoring