Long before a clinical study of your medical device goes into the field, our biostatistician conducts a thorough assessment of the requirements to support a regulatory submission to ensure that your clinical study is planned with the proper enrollment. This pre-clinical biostatistical analysis is very important as under-enrollment can lead to significant market entry delays and over-enrollment can waste money.
Protocol design and analysis
Proper protocol design and analysis will improve the quality of your medical device clinical study submission, control costs and accelerate the introduction of your product to market. Here are some of the clinical study biostatistics services we offer:
- Protocol design and sample size calculations and justification.
- Clinical trial database design and validation.
- Creation of statistical summary tables and reports needed for regulatory submissions.
- Bayesian statistical analysis.
- Final statistical analysis and reporting.
- Extraction of valid datasets for scientific papers or regulatory submissions.
- Statistical audits.
Emergo: international offices and a focus on medical devices
Emergo maintains offices throughout North America, Europe and Asia, so we are able to serve the needs of medical device manufacturers worldwide. We are not a large CRO that focuses on pharmaceutical consulting and does medical device trials as a sideline. Medical devices are our sole focus, meaning your project will get the attention and expertise it deserves, and will likely be completed faster and for less money than might otherwise occur.
Please contact us for additional information on our clinical study and biostatistics services for medical device companies.