Our REMS services are supported by unique expertise and solutions for pharmaceutical risk management and drug safety programs. The BioTrak team is expert at development and implementation of Risk Evaluation and Mitigation Strategies (REMS) programs, including those with Elements to Assure Safe Use (ETASU). When the industry was looking for a solution, we established a best practices approach to conducting REMS assessments that are high quality, reliable, and predictably measure program effectiveness.
BioTrak offers the application of risk modeling assessment tools such as Failure Modes and Effects Analysis (FMEA) and Decision Tree Analysis. Our team can incorporate advanced analytics and statistical support into any project need.