ethica’s statistical services are provided by a department of experienced statisticians. Our statisticians are skilled in the design and analysis of Phase I – IV clinical trials with varying designs such as parallel group, cross-over and Bayesian designs, pharmacokinetic/ pharmacodynamic evaluations, therapeutic equivalence testing and sequential designs.
Our statistical services include:
- Study design and analysis planning
- Central randomization (paper or electronic)
- DSMB support
- Complete final analyses (Phase I – IV)
- Interim analyses
- Post-hoc and exploratory analyses
- Statistical consulting.
eidyiaTM - Extracting knowledge from data
ethica is the only CRO to offer its clients access to a revolutionary analytical tool that is based on a unique form of artificial intelligence. As a series of sophisticated computer programs that evolve, adapt, and interact to generate new computer code and algorithms, eidyiaTM acts as a hypothesis-generator. It is able to extract interdependencies, correlations, and predictive models from complex data sets that conventional statistical tools are unable to detect.
Once identified by eidyiaTM, these relationships are validated using conventional statistical analysis techniques that are understood and accepted by regulatory bodies. Analyses of clinical datasets can yield a variety of new insights including ways to improve the design of subsequent clinical trials and the identification of potential biomarkers (a critical component of personalized healthcare).
eidyiaTM has already yielded successful results in the following areas:
- Identification of biomarkers
- Optimization of biomarker predictive power
- Responder / Non-responder indices
- Models for early diagnosis
- Patient classification
- Phase II responder classification for optimization of Phase III trials