We are no CRO as such, but when it comes to projects aimed at developing or validating new personalized medicine solutions, we bring just the smart touch for data-related tasks to your clinical trial. In sequential order, we can help at each of the traditional steps of a project involving clinical research, in close collaboration with our client teams and the clinical teams involved.
- Setup of the project goals and framework so that they clearly match you subsequent data-analysis challenges: Is it a diagnosis, prognosis, theranosis task? What type of markers should we include/exclude? At what timepoints and frequency should we measure? How to ensure that the solution we have in the end corresponds to the targeted population? What is the impact on inclusion/exclusion criteria?
- Standard of Care: have we sufficient information on the current practice so that we are sure that the data we will collect will enable us to beat this solution? Will the envisioned diag/prog/theranostic tool be easily integrated in clinical practice? Do we know the costs and the QALYs?
- A priori health-economics study: DNAlytics can perform an a priori risk analysis. Even before recruiting the first patient, based on the description of the standard of care, we can measure the range of sensitivity/specificity trade-offs that would be needed at the end of the project in order to be more cost-effective than the standard of care.
At this stage, we also help our partners and clients take go/no-go decisions.
Clinical Phase Preparation
- We contribute to the clinical protocol writing for the following items: endpoint and outcome definitions, so that they match the project goal and will make the predictive modeling feasible; inclusion/exclusion criteria; data types; …
- We fully take in charge the Statistical Analysis Plan (SAP): the more is defined in advance, the more rigorous the analysis will be and the stronger the conclusions.
- Sample size estimation
- Data Management: through the implementation of eCRFs
At this stage, we also help our partners and customers take go/no-go decisions.
Clinical Phase Processing
- SAP execution and reporting
- A posteriori health-economic study: what is the incremental cost-effectiveness ratio of the new solution with respect to standard of care
- We develop online prototypes bringing the developed personalized medicine solutions to life, either for our client’s subsequent trials (for example in the case where a stratification strategy is designed on a Phase II and has to be applied on a Phase III), or to beta-tester clinicians (typically in the context of a new diagnostic or prognostic solution).
After prototyping, we can still help the most promising projects go further, up to market access and commercialization. The RheumaKit web platform enabling deployment of predictive models, sales and administration can be replicated to most third party projects.
Do not wait to face the issues and challenges listed above.