Through analysis of clinical trials of many sponsors(e.g. Roche, GSK, Sanofi-Aventis, Novartis, etc. ) we have identified the early risk indicators for such risk factors as: protocol misconduct, risk of protocol amendment, technical defects of EDC Software, fraud, misconduct of devices, wrong calibration, poor patient recruiting and many others. We are also capable to configure your specific risk indicator.
Do you plan to optimize your monitoring costs and achieve efficiency in monitoring activities? Do you plan to control the risks of the clinical trials and take preventive action in the period, when the problem is still small? Problems do not disappear, they only become bigger. Our data driven approach on early risk indicators provide you a strong mechanism of controlling a clinical trial,
We help you in implementation of the risk based monitoring process, install the software, which searches for the early risk indicators in the clinical data and data defects like: technical defects, misconduct, sloppiness, poor recruiting and even fraud.
We provide you the full solution of the data driven integrated risk based monitoring.
We love the IRBM, because it improves the life science, makes it efficient, safe.
We use the same methods in searching of anomalies in clinical data as NASA uses to search water on the mars surface.