Statistical Support

Study Design and Protocol Development

• We work with you from the very beginning to design a study that’s scientifically rigorous and statistically valid. Our team helps define clear objectives, endpoints, and a methodology that aligns with the study's goals. We ensure the study design is optimized for meaningful results.

Sample Size Calculation

• Accurate sample size calculation is essential to ensure your study has the power to detect meaningful differences. Our statisticians provide precise calculations based on your study parameters, ensuring that your sample size is appropriate for the study objectives and statistical analysis.

Data Analysis and Statistical Methodology

• Turacoz employs advanced statistical techniques to analyze clinical trial data. We provide expert statistical analyses, ensuring results are accurate, reliable, and compliant with regulatory requirements. Our methodologies include both traditional and cutting-edge techniques tailored to your study’s specific needs.

Interim Analysis and Data Monitoring

• For studies involving ongoing monitoring, we offer interim analyses to assess the progress of the trial. This helps in early identification of trends, potential risks, and necessary adjustments, ensuring the trial remains on track and quality control is maintained throughout.

Regulatory Compliance and Reporting

• We ensure all statistical analyses and reports comply with regulatory standards, including FDA, EMA, and ICH guidelines. Our team prepares statistical sections of clinical study reports (CSR) and other regulatory documents with the highest level of accuracy and detail to support regulatory submissions.

Statistical Interpretation and Consultation

• Beyond analysis, we offer comprehensive interpretation of statistical results. Our team helps you understand the implications of the data, providing clear insights into the findings that support informed decision-making and regulatory submissions.

Experienced Biostatisticians

• Our team brings years of experience and expertise in biostatistics and clinical trials across a variety of therapeutic areas, ensuring your study is in capable hands.

Regulatory Expertise

• We understand the regulatory requirements of different regions and ensure all statistical analyses comply with FDA, EMA, and other relevant authorities, making your study submission-ready.

Accuracy and Reliability

• We use scientifically sound methodologies to ensure your data is robust, reliable, and accurate, leading to trustworthy results that support informed decision-making.

Customized Solutions

• Every clinical trial is unique. We tailor our statistical support to meet the specific needs of your trial, ensuring optimal design, analysis, and interpretation for the best possible outcomes.

At Turacoz, we are committed to providing the statistical expertise you need to make informed, data-driven decisions throughout your clinical study. Our comprehensive statistical support ensures your study is designed efficiently, analyzed accurately, and reported in compliance with regulatory standards.

Contact us today to learn how our statistical support can enhance the success and integrity of your clinical study.