A close collaboration of scientific writers and biostatisticians to design your research project and communicate…
A close collaboration of scientific writers and biostatisticians to design your research project and communicate your results with flair.
Our medical and scientific affairs team offers a wide range of writing services, from the development of core study documents only to full medical writing programmes.
Working in synergy with our statisticians, our MSA experts advise you on the best methodological approach, support you in the writing of synopses and protocols, thus ensuring robust clinical results and high level communication of study outcomes.
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
- Medical technology.
And research methodology…
- Traditional frequentist methodologies
- Adaptive frequentist methodologies
- Bayesian studies
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.
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.
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.