Biometrics play an essential role in clinical trials. They help to demonstrate the effectiveness of interventions, evaluation of diagnostic procedures, estimation on the prevalence of side effects, and the validity of existing scientific hypotheses.
Biometrics also help to determine the main outcomes (what exactly is being investigated), and the method of measurement (how the objectives will be estimated). In addition to reducing the extent of bias and unnecessary patient exposure to risk, these chosen evaluation methods play a decisive role in the success of a clinical trial by ensuring that your data is ethically compliant and valid.
We will collect and process patient data as part of your clinical trial. All e-clinical systems comply with US FDA’s 21 CFR Part 11 requirements. Drawing from our deep understanding of regulatory frameworks surrounding data management, we ensure that all data is properly collected, structured, and contextualized for each specific clinical trial.
Clinixir’s approach to data management enables researchers to make reliable data comparisons at all stages of a clinical trial. We turn clinical processes into a form of data tracking and standardization, organizing data in accordance with their respective metadata groups.
As part of good clinical practice, our team of biostatisticians will ensure that your biometric data is interpretable and valid. We will help you coordinate your statistical planning in the initial phase so that you can conduct your clinical trials free of methodological or statistical errors.