Statistical Support at Turacoz

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 in defining clear objectives, endpoints, and a methodology that aligns with the study's goals. We ensure that the study design is optimized for meaningful results.

Sample Size Calculation

• Accurate sample size calculation is essential to ensure that your study has the power to detect meaningful differences. Our statisticians provide precise calculations based on your study’s parameters, ensuring that your sample size is appropriate for the study’s 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 that the 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 that involve 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 the data quality is maintained throughout.

Regulatory Compliance and Reporting

• We ensure that all statistical analyses and reports meet the necessary 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 provide comprehensive interpretation of statistical results. Our team helps you understand the implications of the data, providing clear recommendations and insights that guide your 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 that your study is in capable hands.

Regulatory Expertise:

• We understand the regulatory requirements of different regions and ensure that 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 that 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.

Partner with Turacoz

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 that your study is designed efficiently, analyzed accurately, and compliant with regulatory standards.

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