Biostatistics

ADVANCED BIOSTATISTICAL EXCELLENCE AT ESTERN Medical CRO Life Sciences

ESTERN Medical stays at the forefront of statistical techniques, incorporating the latest methodologies from the literature and those endorsed by regulatory agencies such as the US FDA and EMEA.

Key Strengths of ESTERN Medical’s Biostatistics Services:

1. Cutting-edge Expertise: Our Biostatisticians are equipped with the latest statistical techniques, ensuring alignment with regulatory standards.
2. Regulatory Compliance: We possess critical thinking skills to guide sponsors seamlessly through the regulatory filing process, meeting the standards of agencies like the US FDA, EMEA, and more.
3. Tailored Statistical Plans: Leveraging our extensive experience, we develop customized and statistically rigorous plans for each project. These plans adhere to relevant agency approvals, and FDA/ICH guidance documents, and consider medical and clinical nuances.
4. Data Analysis Execution: Our adept execution of data analysis plans results in report-ready summary tables, data listings, and figures. These outputs are crucial for interpretation and inclusion in study reports or submissions.
5. Verification and Senior Review: Every statistical analysis undergoes a thorough verification and senior review process, ensuring accuracy and completeness.

Comprehensive Biostatistical Services at ESTERN Medical:

1. Study Design: Crafting robust study designs that align with the project’s objectives and regulatory requirements.
2. Analysis Planning: Developing detailed plans for data analysis, considering regulatory guidance and medical nuances.
3. Data Monitoring Committee (DMC): Statistical Support: Offering statistical support for Data Monitoring Committees to ensure ongoing data integrity.
4. Adaptive Design Simulation & Statistical Modeling: Utilizing advanced simulation and modeling techniques for adaptive study designs.
5. Randomization Schedule Preparation: Preparing randomized schedules to ensure unbiased and controlled allocation of subjects.
6. Statistical Programming, Validation, and Reports: Executing statistical programming, conducting thorough validation processes, and generating comprehensive reports.

ESTERN Medical’s commitment to biostatistical excellence is evident in our ability to seamlessly integrate cutting-edge methodologies, regulatory compliance, and meticulous execution into each project. Our Biostatistics Services contribute to the generation of robust and reliable statistical outputs critical for informed decision-making and successful regulatory submissions.