Risk-based monitoring can help revolutionize clinical trials. It helps companies focus on patient safety, quality of clinical data and can help to drive efficiency. Trancelerate Biopharma's goal for this particular matter is to Develop an industry-wide standard and approach for risk-based monitoring of clinical trials in order to enhance patient safety and ensure the quality of clinical trial data.
According to Pharma Times Online, in the new paper released by TransCelerate Biopharma, they've detailed two items that will help drive risk-based monitoring by driving centralized and off-site monitoring tools and adaptive on-site monitoring. To reach these goals they've proposed two measures: risk assessment categorisation tool (RACT) and an integrated quality and risk management plan (IQRMP).
To find out more, visit the webpage to download the paper.
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