Expert Statistical Consulting for Robust Clinical Insights
At DeSia, we recognize that accurate statistical analysis is critical for deriving meaningful insights from clinical study results and Post-Market Clinical Follow-up (PMCF) surveys or studies. Our team of experienced biostatisticians provides comprehensive statistical consulting services tailored to meet the unique needs of your clinical research and post-market activities.
Our Statistical Consulting Services Include:
Data Analysis and Interpretation:
- Applying advanced statistical methods to analyze clinical study results and PMCF data.
- Interpreting complex data sets to derive clear, actionable insights.
- Providing detailed reports and visualizations that facilitate understanding and decision-making.
Study Design and Statistical Planning:
- Assisting in the design of clinical studies and PMCF surveys to ensure robust and valid statistical outcomes.
- Developing comprehensive statistical analysis plans (SAPs) that outline methodologies, data handling, and analysis strategies.
- Ensuring alignment with regulatory standards and best practices in biostatistics.
Interim and Final Analyses:
- Conducting interim analyses to monitor study progress and make necessary adjustments.
- Performing final data analyses to draw conclusive results and support regulatory submissions.
Power and Sample Size Calculations:
- Determining appropriate sample sizes to ensure statistical power and reliability of study results.
- Providing guidance on optimizing study design to achieve meaningful outcomes with available resources.
Survival Analysis and Time-to-Event Data:
- Analyzing survival data to evaluate time-to-event outcomes, such as progression-free survival or overall survival.
- Applying methods like Kaplan-Meier estimation and Cox proportional hazards modeling.
Regression and Multivariate Analyses:
- Using regression techniques to explore relationships between variables and outcomes.
- Implementing multivariate analyses to control confounding factors and identify key predictors.
Meta-Analyses:
- Conducting meta-analyses to synthesize data from multiple studies, providing a comprehensive view of treatment effects or device performance.
- Ensuring rigorous methodology and transparent reporting to support evidence-based conclusions.
Tailored Approach for PMCF Studies:
Customized Statistical Plans:
- Developing statistical analysis plans specifically for PMCF studies to monitor ongoing device performance and safety.
- Utilizing PMCF data to validate and enhance product claims, ensuring continuous compliance with regulatory requirements.
Longitudinal Data Analysis:
- Analyzing data collected over time to assess changes in performance and identify trends.
- Implementing techniques like mixed-effects models and repeated measures ANOVA.
Real-World Evidence Generation:
- Leveraging PMCF data to generate real-world evidence (RWE) that supports the safety and effectiveness of medical devices.
- Providing insights that inform product improvements and regulatory updates.
Why Choose DeSia for Statistical Consulting:
- Expertise: Our team of skilled biostatisticians brings extensive experience in clinical and post-market data analysis.
- Customized Solutions: We tailor our services to meet the specific needs of each study, ensuring relevant and reliable results.
- Regulatory Compliance: Our analyses adhere to the highest standards, supporting regulatory submissions and compliance.
Partner with DeSia for Expert Statistical Consulting
For comprehensive and expert statistical analysis services that enhance the value and impact of your clinical studies and PMCF activities, contact DeSia at info@desiaclinical.com. Let us help you unlock the full potential of your data through rigorous and insightful statistical consulting.
