What We Do

BioTrak specializes in custom consulting services for Risk Evaluation and Mitigation Strategy (REMS) program design and assessment, comprehension studies for medical education materials and labeling, usability studies for medical products, patient reported outcomes (PROs), and other observational research study initiatives.

Our PharmaTrak™ Research program specifically offers unique expertise and solutions for pharmaceutical risk management and drug safety programs, e.g.:

• 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.  Learn more
• Application of risk modeling assessment tools, including use of simulation software programs like @RISK, PrecisionTree, and RISKview. These tools are often applied to creating models that predict the best probable outcomes among a range of risk management options.
• Advanced analytics and statistical support.

Our Periapproval Services include registries and electronic patient reported outcomes (ePROs). We can develop and implement custom registry solutions for patients, health care providers and pharmacists. We also can design and administer a full ePRO trial. Learn more