Design of Experiments (DOE):
We assist in the design and analysis of experiments to optimize processes and products. By applying robust statistical methods, we identify the key factors influencing the outcomes and ensure the most efficient use of resources while minimizing variability.
Data Analysis and Interpretation:
Our team of statisticians analyzes complex data from clinical trials, manufacturing processes, and laboratory tests. We employ advanced statistical techniques such as regression analysis, hypothesis testing, and multivariate analysis to provide actionable insights that help improve product quality and operational efficiency.
Risk Assessment and Management:
Statistical methods are key in assessing risks within the pharmaceutical industry. Curedose Pharma supports you by conducting risk assessments using statistical models to predict potential failures or inefficiencies, helping you make informed decisions to mitigate those risks effectively.
Stability Studies and Trend Analysis:
We assist in the design and statistical analysis of stability studies, ensuring that pharmaceutical products meet shelf-life requirements. Our support includes trend analysis to monitor and assess the stability of drug products over time, providing vital information for regulatory submissions.
Clinical Trials Data Analysis:
Curedose Pharma provides expert statistical support in the design, analysis, and interpretation of clinical trial data. We ensure that statistical methodologies comply with regulatory guidelines (e.g., ICH, FDA) and help you to interpret trial results with clarity, ensuring proper understanding and submission readiness.
Sample Size Calculation and Power Analysis:
To ensure the statistical reliability of studies, we calculate appropriate sample sizes and conduct power analyses. This helps you avoid underpowered studies and ensures that your trials have sufficient power to detect meaningful differences.
Process Control and Quality Control (QC) Statistics:
We apply statistical process control (SPC) tools to monitor and maintain the quality of your manufacturing processes. By using control charts and other QC statistical tools, we help you identify potential issues early, ensuring your production is consistently compliant with industry standards.
Regulatory Submission Support:
Our statistical investigation support is aligned with regulatory requirements. Whether for IND submissions, NDA filings, or post-market surveillance, we provide you with the necessary statistical analysis and reporting to meet regulatory expectations and facilitate approval processes.
