Welcome to Zuality, Your trusted data and technology partner, we are dedicated to providing top-tier services in Clinical Data Management, Biostatistics, Statistical Programming, and more...


USA Office:
7950 Legacy Drive,Suite 400,Plano, TX 75024.
Phone: +1 (510) 386-8244.

Madurai Office:
#36/2, Doak Nagar Main Road, Doak Nagar Extension, Madurai – 625010.
Phone: +91-(452)-3012448.

Chennai Office:
#1, Anthu Street, Santhome High Road, Chennai – 600004.
Phone: +91-(44)-43033730.

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Welcome to Zuality - Your trusted data and technology partner

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Biostatistics

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Biostatistics

Our Biostatistics services offer expert statistical analysis and consulting to optimize your clinical trials.

Our team of seasoned biostatisticians provides strategic guidance on study design, ensuring robust and scientifically sound methodologies.

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about

We have 2563+ Global Active Clients

We conduct rigorous data analysis and interpretation to deliver clear, actionable insights that support the trial objectives. Additionally, we prepare detailed statistical reports and documentation to facilitate successful regulatory submissions. With our comprehensive biostatistical expertise, we empower you to make data-driven decisions and achieve reliable, impactful clinical outcomes.Our rigorous data cleaning and validation processes guarantee data accuracy and adherence to regulatory standards. Additionally, we securely manage database locking and archival, ensuring your data is preserved for future reference and analysis. With our expertise, we deliver precise and reliable data to support informed decision-making and drive successful clinical outcomes.

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Key Services

Statistical Consulting: Offering expert advice on study design, including determining sample size, power calculations, and statistical methodologies to ensure robust and scientifically valid results.

Randomization and Blinding: Designing and implementing randomization schemes to minimize bias and ensure the integrity of the study.

Development of SAP: Creating detailed Statistical Analysis Plans (SAPs) that outline the statistical methodologies and analysis strategies, ensuring clear and predefined objectives and methods.

Mock Tables, Listings, and Figures (TLFs): Preparation of mock TLFs to outline expected results and assist in planning the data analysis phase.

Interim Analysis: Conducting interim analyses to provide early insights while maintaining the integrity and blinding of the study.

Final Analysis: Comprehensive analysis of primary and secondary endpoints, including efficacy, safety, and exploratory analyses, ensuring all regulatory and scientific requirements are met.

Modeling and Simulation: Utilizing advanced statistical models and simulations to predict outcomes and assess trial design robustness.

Adaptive Design: Expertise in adaptive trial designs, allowing for modifications based on interim results to optimize study outcomes.

Interpretation of Results: Providing clear, concise, and scientifically accurate interpretations of the statistical analyses.

Clinical Study Reports (CSR): Preparation of CSRs, including detailed statistical sections, to summarize study findings and support regulatory submissions.

Integrated Summaries: Preparation of Integrated Summaries of Safety and Efficacy (ISS/ISE) and other regulatory submission documents.

Regulatory Interactions: Supporting interactions with regulatory agencies, including responses to statistical queries and participation in meetings and discussions.

Post-Hoc Analysis: o Conducting additional analyses to explore data beyond the predefined endpoints, providing deeper insights into the study results.

Data Visualization and Reporting: Creating detailed data visualizations and reports to facilitate the interpretation and presentation of complex data.

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Benefits of Our Biostatistics Services

Scientific Rigor: Our biostatisticians ensure that all analyses are conducted with the highest scientific and statistical rigor, supporting credible and reliable study outcomes.

Regulatory Expertise: Extensive experience in preparing regulatory submissions and interacting with agencies, ensuring compliance and facilitating smooth approval processes.

Custom Solutions: Tailored biostatistical support to meet the specific needs of each clinical trial, from small-scale studies to large, multi-center trials.

Efficiency and Quality: A commitment to delivering high-quality results efficiently, using best practices and advanced statistical methodologies.

Collaborative Approach: Working closely with clinical and data management teams to ensure seamless integration of statistical analyses with overall study objectives.

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At Zuality, our Biostatistics services are designed to provide comprehensive statistical support for clinical trials, from initial design through to final reporting. We are dedicated to delivering high-quality, accurate, and compliant statistical analyses that enhance the credibility and success of your clinical research.