FDA Risk Evaluation and Mitigation Assessment

Risk Evaluation and Mitigation Strategy (REMS) Assessments

Risk Evaluation and Mitigation Strategies (REMS) programs
Design, management, and reporting for FDA REMS assessment, EMA Risk Management Plan, and other risk management initiatives.

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Human Factors Research & Usability Studies

Usability Testing
Healthcare professional and consumer focused research studies to evaluate usability and performance with drug-device combination products and medical devices.

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Labeling Comprehension

Labeling Comprehension Studies
Research testing to qualitatively and quantitatively evaluate readability and understanding of professional and consumer medical information.

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Biotrak Research - Confidence & Insights… From Domain Area Experts to Proprietary Analytical Tools

 BioTrak Research The design and reliability of your research data collection translates to greater insights and confidence in understanding and predicting behavior towards your medical product. BioTrak Research gathers and analyzes reliable data through applying its vast expertise and innovative research tools, such as ASSESS, the first-ever analysis tool and database for benchmarking REMS assessments.

Our comprehensive research testing and evaluation methods include:
  • Knowledge, Awareness and Behavior (KAB) studies and Awareness, Trial, and Usage (ATU) studies.
  • Observational research such as labeling comprehension, actual use studies, usability testing, human factors research, and readability testing
  • Failure Modes and Effects Analysis (FMEA) and other hazard analysis methods
  • Testing and development of consumer medical information (CMI) and healthcare provider (HCP) communications
  • Medical professional and patient confidential surveys
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Please contact BioTrak Research at info@biotrak.com or call 760 448.4820 to learn more.