By partnering with ICTA, you are joining forces with a dedicated team of scientific writers…
Design
By partnering with ICTA, you are joining forces with a dedicated team of scientific writers and biostatisticians who will lay the groundwork for your research project and present your results with precision and impact.
Our Medical and Scientific Affairs (MSA) experts provide a comprehensive range of customisable writing services, from drafting essential study documents to overseeing extensive medical writing programmes.
Working in close collaboration with experienced statisticians, we ensure that your research benefits from the most effective methodological approaches. We support you in developing study synopses, drafting detailed protocols and achieving rigorous clinical results.
Designing Success: Enhance Your Clinical Study Design with a CRO of reference since 1984
Here are 2 things you can count on when ICTA takes care of your protocol design, whether it is pre- or post-approval.
A critical review
of articles and available data
A critical analysis of the current state of knowledge on the research question (i.e. the formulated hypothesis) is required to conclude that the project is relevant, and this analysis must guide its conception.
A METHODOLOGICAL INPUT FOR THE DESIGN
OF THE STUDY PROTOCOL
This stage involves multidisciplinary reflection from all clinical R&D disciplines, particularly clinicians and biostatisticians who are trained in statistical methodology.
WE COVER ALL STUDY TYPES
- 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.
INVESTIGATE NUMEROUS HEALTH PRODUCTS
- Traditional « new chemical entities » and biotechnology-based molecules
- Cell and gene therapies
- Immunotherapies
- Antibodies
- Vaccinology
- Medical technology.
AND USE MANY RESEARCH METHODOLOGIES
- Traditional frequentist methodologies
- Adaptive frequentist methodologies
- Bayesian studies
- Algorithms
WITH US, YOU’LL EXPEDITE YOUR DRUG OR MEDICAL DEVICE DEVELOPMENT PROGRAMS
ICTA experts can help accelerate your drug or medical device development programs by providing insights and guidance. They will act at different steps of the clinical study.
in early phase clinical studies
ICTA’s Medical and Scientific Affairs and Biometry teams can support clients in choosing their methodological approach, whether it is traditional, adaptive, frequentist or Bayesian. They can also assist with designing study protocols and developing specifications based on the chosen approach.
in post-registration
studies
Our service provides clients with an analysis plan for data enhancement, incorporating frequentist and Bayesian inference methodologies, descriptive analysis, data mining and neural networks, whether or not it is integrated into a risk management plan.
in decentralised
studies
Pave the way for the future by benefiting from a pragmatic analysis focusing on the advantages, regulatory impact and available digital solutions. ICTA has the expertise to design the most suitable study, taking into account the acceptance of new approaches by national health authorities, ethics committees, and national health data protection agencies.
Other services
Regulatory affairs
Regulatory hurdles don’t have to slow you down. Our expert team stays continuously updated on…
Project management
Expert Project Management That Drives Clinical Success At ICTA, project management is more than coordination—it's…
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…
