Glossary Term
Biostatistics
Definition
Biostatistics is the application of statistical methods to analyze and interpret data related to biological and medical research. In the MedTech industry, biostatistics is crucial for designing studies, analyzing clinical trial data, and validating the safety and efficacy of medical devices and therapies.
Relevance to the MedTech Industry
Biostatistics ensures the rigor and reliability of clinical and preclinical research by providing tools to assess data objectively. It plays a key role in demonstrating compliance with regulatory standards, optimizing study designs, and making data-driven decisions throughout the product lifecycle.
Additional Information & Related Terms
Clinical Trial Design Relies on biostatistics to structure and evaluate studies.
P-Value A statistical measure commonly used to evaluate the significance of clinical trial results.
Post-Market Surveillance Uses biostatistical methods to analyze real-world device performance.
Regulatory Submissions Include biostatistical evidence to support claims of safety and efficacy.