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, and other observational research study initiatives.
Experts at your service
Our client services are lead by an area expert who not only oversees the research process, but is directly responsible for the conduct of the research and subsequent analysis and report writing. We believe this personal touch approach is fundamentally different than what a client might have experienced with large contract research organization.
Our Pharmaceutical Risk Management research services specifically offer unique expertise and solutions for 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.
- 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 Human Factors research services include labeling comprehension studies, usability studies, and human factors engineering studies.
- 30 years of medical industry commercial experience
- Project leader/director on over 250 consulting assignments involving REMS, Risk Management Plans and drug safety programs, human factors research, labeling comprehension, product planning, commercial strategy, and commercial support services. This included over 40 REMS programs, over 200 web-hosted patient and prescriber surveys, and a broad range of drug safety and commercial research.
- Managed 20 new product launches – 3 Rx, 17 Dx
- Built 2 specialty pharma commercial programs from ground up
- Designed novel, reliable and predicable methods for REMS assessments
- Protocol and survey development
- Survey design, programming, QC and validation, web hosting
- HCP and patient recruitment using varied recruitment methodologies
- Management of HCP and patient call-center
- Management of all REMS materials per Quality Program guidelines
- Assist in REMS assessment report development, data collection and reporting