A scientific publication is just the peak of the iceberg in a clinical trial
Setting up a clinical trial with your co-investigators is not always easy, as trial design, regulatory compliance, professional statistical analysis and publication drafting are a complex environment to deal with.
Research Group provides independent investigators with professional competencies in all steps of a clinical trial conduct, with inexpensive solutions and full-time support throughout the duration of the study.
Are you ready to astonish the Ethical Committee with a state-of-art clinical study protocol?
Observational and quasiexperimental studies are the best choice to let an independent investigator to contribute to the development and acquisition of new evidence about safety and efficacy of an IMP.
The scientific background and rationale are the most relevant keys to set appropriate study endpoints. Moreover, an appropriate study population is identified through sound selection criteria.
Clinical data capture strategy and management
Data are the pillars which evidence is built on. Digital or traditional data collection have strict rules to follow, for ensuring consistency of proofs, intrinsic validity of the trial and to allow a successful data anlysis.
Design a good and friendly-to-use CRF/eCRF and provide appropriate investigator training are mandatory for a successful trial.
Regulatory support for nonprofit studies
Nonprofit clinical research is represented by those studies without a lucrative aim, which collected data are not used for commercial and industrial development purposes, while is mainly focused on the improvement of clinical practice.
With the EU Regulation n.536/2014, nonprofit studies have gained a number of advantages, either for interventional or observational design.
Clinical data analytics and statistical reports
Data analysis is a key operation to draw conclusions from the trial. Statistical models for clinical data should be always designed in advance, to optimize timing and resources of data analysis.
Real time analytics can be provided through electronic data capture, and artifical intelligence models can be applied on real world big data.
Although a scientific article is only the peak of the iceberg of a clinical trial, publication of results is one of the best ways to improve knowledge and to develop further research on the same medical question.
Drafting a good paper needs experience, technical language and lots of patience to find the best journal to which submit the manuscript.