Biostatistics for Medical Device Clinical Studies
Our biostatisticians can provide valuable input to the design of your clinical study. We will conduct a thorough assessment of the scientific requirements to ensure your clinical study is planned with the proper sample size (number of patients included in the study) and design as well as the evaluation methods.
Proper protocol design and analysis will improve the quality of the medical device clinical study submission for approval, contribute to cost-efficiency, and help accelerate the introduction of your product to market.
Here are some of the clinical study biostatistics services we offer:
- Input to the protocol design
- Sample size calculations and justification
- Statistical analysis planning
- Interim/final statistical analysis and reporting
- Creation of statistical summary tables and reports needed for regulatory submissions
- Statistical support for Notified Body and FDA discussions
- Extraction of datasets for scientific papers
- Provide input for regulatory documents, such as input for CER, IFU, Summary of Safety and Efficacy
Emergo Clinical: the CRO with a focus on medical devices
We are not a large pharmaceutical CRO that does medical device trials as a sideline activity. Medical devices and combination products are our sole focus, meaning your project will get the attention and expertise it deserves.