Partnering with ICTA is partnering with a dedicated team of scientific writers and biostatisticians to…
Design
Partnering with ICTA is partnering with a dedicated team of scientific writers and biostatisticians to create a robust foundation for your research project and present your results with precision and impact.
Our Medical and Scientific Affairs (MSA) experts provide a full spectrum of writing services tailored to your needs, from crafting essential study documents to managing comprehensive medical writing programs.
By working in seamless collaboration with experienced statisticians, we ensure your research benefits from the most effective methodological approaches. Our team supports you in developing study synopses, drafting detailed protocols, and achieving rigorous clinical results.
WHAT ARE THE FUNDAMENTAL STEPS
TO BEST DESIGN A PROJECT IN CLINICAL R&D?
The design of a protocol, pre- or post-approval, or of a
a development plan requires:
A critical review
of articles and available data
The critical analysis of the current state of knowledge on the research question (i.e. the hypothesis formulated) must conclude that the project is relevant and must guide its conception.
A METHODOLOGICAL INPUT FOR THE DESIGN
OF THE STUDY PROTOCOL
This stage involves a multidisciplinary reflection involving all the disciplines that make up clinical R&D, in particular clinicians and biostatisticians trained in statistical methodology.
Regardless of the type of study…
- Superiority, non-inferiority, and equivalence studies and translational research
- Cross-sectional, cohort, case-control studies
- Medical device studies, including diagnostics
- Secondary data use studies including database analysis.
Health product investigated…
- Traditional « new chemical entities » and biotechnology-based molecules
- Cell and gene therapies
- Immunotherapies
- Antibodies
- Vaccinology
- Medical technology.
And research methodology…
- Traditional frequentist methodologies
- Adaptive frequentist methodologies
- Bayesian studies
- Algorithms
EXPEDITE YOUR DRUG
OR MEDICAL DEVICE DEVELOPMENT PROGRAM
ICTA experts can help you accelerate your drug or medical device development program by providing with insights and guidance
in early phase clinical studies
ICTA’s medical and scientific affairs team and biometry team can support clients in the choice of their methodological approach, whether traditional, adaptive frequentist or Bayesian, and can assist them in the design of their study protocol and the development of specifications based on the chosen approach.
in post-registration
studies
Whether or not it is integrated into a risk management plan, our service provides clients with an analysis plan for data enhancement, incorporating frequentist and Bayesian inference methodologies, as well as descriptive analysis, data mining and neural networks.
in decentralised
studies
To pave the way for the future… Benefit from a pragmatic analysis focusing on the advantages, regulatory impact and available digital solutions. ICTA already has the know-how to define the best study design anticipating the acceptance of new approaches by national health authorities, ethics committees and national health data protection agencies.
Other services
Regulatory affairs
To help you successfully navigate regulatory hurdles. Always up to date on the latest regulations…
Project management
A strong and centralised project management organisation supported by a robust IT platform. Centralised at…
Site Support
Do you need experienced Clinical Research Assistants to assist you? Our Clinical Research Assistants /…
Risk-based monitoring
An agile approach to improve data quality, ensure study continuity and reduce site burden. We…
Data management
Our Data Management team’s motto can be summed up in 5 words: QUALITY, DATA INTEGRITY,…
Biostatistics
ICTA biometry services to generate high-quality and reliable data for informed decision making. Benefit from…
Medical writing
ICTA offers a range of flexible medical writing solutions to support your clinical program needs…
