Reliability in your risk-assessment and observational research data leads to greater insights and confidence towards successful FDA acceptance and proper use of your pharmaceutical product.
BioTrak Research gathers and analyzes reliable data through innovative Risk Evaluation and Mitigation Strategy (REMS) assessment research tools, such as ASSESS, the first-ever analysis tool and database for benchmarking your REMS performance data with similar REMS programs. Our comprehensive product safety and usability research methods include:
- REMS program design, assessment and analysis solutions
- Observational research, including labeling comprehension and actual use studies, user acceptance testing, readability testing
- Testing and development of consumer medical information (CMI) and healthcare provider (HCP) communications
We look forward to speaking with you about your research needs. Please contact BioTrak Research at info@biotrak.com or call 760. 448. 4820 to learn more.
View our REMS Capabilities Presentation
View our Observational Research Capabilities and Case Studies
