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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.
Welcome to Zuality - Your trusted data and technology partner
Our ServicesOur Statistical Programming services provide robust and tailored programming solutions to meet the unique needs of your clinical trials.
Our team of skilled SAS programmers develops and validates high-quality programs for data transformation (SDTM), analysis, and reporting (ADaM and TLFs), ensuring compliance with CDISC.
We offer customized programming solutions that enhance the efficiency and accuracy of your data analysis, facilitating regulatory submissions and supporting informed decision-making. With our expertise in statistical programming, we empower your clinical research with precise, reliable, and actionable insights.
Statistical ProgrammingProgramming Specifications: Development of detailed programming specifications based on the Statistical Analysis Plan (SAP), ensuring clarity and consistency in data analysis.
Mock Shells: Creation of mock shells for tables, listings, and figures (TLFs), providing a blueprint for the final outputs.
Data Standardization: Ensuring consistency and adherence to CDISC standards, including SDTM and ADaM datasets.
Data Cleaning: Rigorous cleaning processes to identify and resolve any data issues, ensuring the integrity and quality of the datasets.
ADaM Datasets: Development of Analysis Data Model (ADaM) datasets that facilitate the reproducibility of statistical analyses and compliance with regulatory requirements.
Derived Datasets: Creation of derived datasets tailored to specific analyses, supporting a wide range of statistical methods and exploratory analyses.
Custom TLFs: Programming and generation of customized tables, listings, and figures that meet the specific requirements of the study and regulatory submissions.
Automation and Validation: Use of automated processes and double programming to validate TLFs, ensuring accuracy and consistency.
Interim Analysis: Programming support for interim analyses, including data cutoff and blinded data review.
Final Analysis: Comprehensive programming for final data analysis, including efficacy and safety endpoints, subgroup analyses, and exploratory endpoints.
Integrated Summary of Safety and Efficacy (ISS/ISE): Programming and preparation of ISS/ISE datasets and outputs for regulatory submissions.
Regulatory Submission Datasets: Creation of submission-ready datasets and documentation, including define.xml files and annotated CRFs, compliant with FDA, EMA, and other regulatory agencies’ requirements.
SAS Macros and Automation: Development and use of SAS macros to standardize and streamline programming processes, ensuring consistency and efficiency.
Quality Control (QC): Rigorous QC processes, including code review and dataset validation, to ensure the accuracy and reliability of all programming outputs.
Exploratory Data Analysis: Support for exploratory and ad hoc analyses, providing insights beyond the predefined statistical analyses.
Data Visualizations: Creation of advanced data visualizations to support data interpretation and decision-making.
Statistical Programming Expertise and Experience: Our team comprises highly skilled statistical programmers with extensive experience in clinical trials and regulatory submissions.
Quality and Accuracy: We prioritize accuracy and quality through meticulous programming practices and comprehensive validation processes.
Regulatory Compliance: Our deliverables are fully compliant with international regulatory standards, including CDISC, ensuring smooth regulatory submissions.
Efficiency and Timeliness: Efficient workflows and advanced tools enable us to deliver high-quality outputs within tight timelines.
Customization and Flexibility: We provide tailored programming solutions to meet the unique needs of each study, accommodating various trial designs and analytical requirements.
At Zuality, our Statistical Programming services are an integral part of the clinical trial process, ensuring that data is correctly analyzed and presented in a clear, regulatory-compliant format. We are committed to delivering high-quality, reliable programming solutions that support informed decision-making and successful regulatory submissions.