At EPINTEK, we offer comprehensive biostatistical analysis services tailored specifically to the needs of medical device clinical trials. Our expert team provides data-driven support throughout the entire trial process, ensuring scientific rigor, regulatory compliance, and reliable outcomes.
1. Sample Size Calculation for Medical Device Clinical Trials
Accurate sample size estimation is crucial to ensure a study has sufficient statistical power to detect meaningful differences. Our statisticians use advanced methodologies and take into account the specific characteristics of the medical device and trial design to determine an appropriate sample size that meets both scientific and regulatory requirements.
2. Statistical Support in Clinical Trial Protocol Design
We provide strategic input during the protocol development phase, helping define primary and secondary endpoints, select appropriate statistical methods, and structure the trial for optimal efficiency and validity. This early involvement ensures that the trial is well-positioned for success from a statistical perspective.
3. Randomization Design and Implementation
Randomization is a key component of controlled clinical trials. We design and implement randomization schemes tailored to each trial’s needs, including simple, block, stratified, and adaptive randomization methods. These strategies help minimize selection bias and ensure balanced treatment groups.
4. Blinding Design and Implementation
Maintaining objectivity in clinical trials requires effective blinding techniques. We assist in designing and implementing single-blind, double-blind, or even complex multi-arm blinding strategies, depending on the nature of the device and the trial setting.
5. Statistical Analysis Plan (SAP)
A detailed Statistical Analysis Plan is developed prior to the final analysis to outline all planned statistical methods, analysis populations, handling of missing data, and criteria for statistical significance. Our SAPs are fully aligned with international regulatory standards and serve as a transparent framework for data analysis.
6. Statistical Analysis Report
Following data collection and cleaning, our team conducts comprehensive statistical analyses using validated software such as SAS. The final statistical analysis report includes descriptive statistics, inferential analyses, graphical summaries, and interpretations, providing stakeholders with clear insights into the performance and safety of the medical device.
EPINTEK's biostatistics team plays a vital role in supporting medical device companies through every stage of clinical development. With deep expertise in regulatory requirements and a strong commitment to quality, we help clients generate robust evidence to support product registration and market approval.
For more information about our biostatistical services or to discuss your project needs, please contact us today.
