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Risk Evaluation and Mitigation Strategy (REMS)

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


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

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comprehension studies


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

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BioTrak is an innovator of healthcare market research and has pioneered the application of probabilistic forecast modeling.

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BioTrak research –
confidence & insights from domain area experts to proprietary analytical tools

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