For first-in-human trials, a key element of our approach is the use of our IB-Derisk tool, which helps identify potential risks in preclinical data. By organising the data based on the maximal concentration (Cmax) achieved in preclinical studies and colour-coding the results, IB Derisk provides a visual overview of the compound’s effects. This makes it easier to spot irregularities and potential risks, ensuring that important details are not overlooked and enhancing the safety of early clinical studies.
To further ensure the highest standards of safety and scientific integrity, all study designs are rigorously reviewed by our internal Scientific Advisory Board. This expert team carefully examines each design before it is submitted to ethics committees, adding an extra layer of scrutiny to safeguard the quality and safety of the study.
If required, we can also write a comprehensive clinical study protocol based on the developed study design. Our protocol writing service ensures that all regulatory, ethical, and scientific standards are met by using proven templates that align with ethics committee expectations, minimising administrative delays and facilitating a smooth trial initiation.
