Business Details
27 Years
experience
Pharmaceutical Risk Management & Medical Research Services
Founded in 1999, Biotrak has established itself as a leader in pharmaceutical risk management and medical research. Our expertise spans REMS program design, labeling comprehension studies, and human factors research, serving clients across the healthcare industry. With over 25 years of experience, we pioneered innovative methodologies like the ASSESS analysis tool to enhance drug safety and compliance. Our team of domain experts directly oversees all research initiatives, ensuring rigorous data collection and analysis tailored to client needs. We specialize in observational studies, including usability testing, failure modes analysis, and probabilistic forecasting models.Our work supports over 40 REMS programs and 200+ patient surveys, demonstrating measurable improvements in medication safety. Headquartered in Southlake, Texas, we combine scientific rigor with practical insights to deliver actionable solutions for global healthcare challenges. Our client-centric approach prioritizes transparency, reliability, and regulatory compliance in every project. Through continuous innovation, we maintain industry leadership in risk evaluation and mitigation strategies. Our commitment to excellence has made us a trusted partner for pharmaceutical companies seeking evidence-based solutions.
Services
REMS Assessments
Labeling Comprehension
Usability Studies
Human Factors Research
Market Forecast Modeling
Drug Safety Programs
Observational Research
Risk Management Plans
Medical Device Testing
Pharmaceutical Consulting
Details
- Year established: 1999
Highlights and features
- We have 25 years of experience in pharmaceutical risk management research
- Our team includes pioneers of REMS assessment best practices
- We developed ASSESS, the first REMS benchmarking analysis tool
- Direct expert oversight ensures research quality and accountability
- Proven track record with 40+ REMS programs and 200+ surveys
What people say
Proven track record
Expert analysis
Regulatory compliance
Innovative methodologies
Measurable results
Services
REMS Assessments
Risk Evaluation and Mitigation Strategy (REMS) assessments ensure FDA compliance through rigorous program design and effectiveness measurement. Our proprietary ASSESS tool benchmarks program performance, supporting over 40 REMS initiatives. We provide comprehensive reporting to demonstrate regulatory compliance and improve medication safety outcomes.
Labeling Comprehension
We evaluate medical labeling effectiveness through observational studies measuring readability and understanding among healthcare providers and patients. Our science-based methods identify comprehension gaps in medication guides and package inserts, ensuring clear communication of critical safety information.
Usability Studies
Human factors research assesses medical product usability through simulated use testing and failure modes analysis. Our studies identify potential use errors with drug-device combinations, supporting safer product design and regulatory approval processes for medical devices.
Market Forecast Modeling
Proprietary probabilistic modeling predicts market outcomes using simulation software like @RISK and PrecisionTree. Our forecasting models guide risk management decisions and commercial strategy for pharmaceutical products, incorporating variables like adoption rates and regulatory impacts.
Human Factors Research
We conduct comprehensive human factors engineering studies to evaluate medical product interactions. Our research combines usability testing with observational data to identify risks in real-world usage scenarios, improving patient outcomes through evidence-based design improvements.
People
Larry A. Risen
President and CEO
Founder of BioTrak with 30 years medical industry experience. Led 250+ consulting assignments including 40 REMS programs. Developed innovative REMS assessment methods and authored industry publications. Holds BS in Biology and MBA.
Questions
What REMS services do you offer?
We provide full REMS program design, assessment, and reporting including ETASU implementation and effectiveness measurement through proprietary analytical tools.
How do you test medical labeling effectiveness?
We conduct observational studies measuring comprehension among healthcare providers and patients using science-based readability analysis and benchmarking methods.
What makes your research approach unique?
Our experts directly oversee all research with proprietary tools like ASSESS, combining 25 years of experience with innovative methodologies for actionable insights.
Do you work with international clients?
Yes, our services support global pharmaceutical companies with regulatory compliance strategies applicable to FDA, EMA, and other international requirements.
How can I request a consultation?
Contact us via phone at 760-668-4524 or through our website contact form for a response within one business day.
