Statistical Programming
Our team excels in developing, validating, and executing complex statistical analyses using industry-leading tools and software. We ensure seamless integration with clinical data management systems and adherence to regulatory standards, delivering accurate and timely results. From creating SDTM and ADaM datasets to generating TLFs (tables, listings, and figures), our robust solutions streamline the submission process, enhance data integrity, and support informed decision-making throughout the product lifecycle
What we do?
Our expertise ensures precise, reliable data that guides your product from early stages to post-approval
Data Mapping and Transformation
Convert raw clinical data into CDISC-compliant SDTM and ADaM datasets. Our experts utilize advanced programming techniques to ensure accurate data mapping and transformation, facilitating seamless data analysis and regulatory submissions
Table, Listing, and Figure (TLF) Generation
Develop high-quality TLFs to support clinical trial reporting. We use sophisticated statistical programming to produce clear, accurate, and regulatory-compliant outputs that aid in data interpretation and decision-making
Validation and Quality Control
Implement rigorous validation and quality control processes. Our team conducts comprehensive checks on all datasets and outputs, ensuring accuracy, consistency, and compliance with regulatory guidelines
Custom Statistical Analysis
Design and execute custom statistical analyses tailored to your study needs. Our skilled programmers develop bespoke analysis plans and scripts to address specific research questions and hypotheses, ensuring precise and insightful results
Regulatory Submission Support
Ensure your statistical programming outputs meet regulatory requirements. We provide comprehensive support for the preparation and review of submission packages, including datasets, TLFs, and documentation
Training and Consultation
Empower your team with expert training and consultation. Our experienced programmers offer tailored training sessions and ongoing support to enhance your team’s capabilities in statistical programming and data analysis
Our Differentiators
Our expertise ensures precise, reliable data that guides your product from early stages to post-approval
Advanced Statistical Methods
Leverage our 10 years of expertise to implement sophisticated statistical methodologies, ensuring robust and reliable analysis of your clinical trial data
Regulatory Compliance
Our team ensures that all statistical programming adheres to the latest regulatory requirements, enhancing the likelihood of smooth submissions and approvals
Integration with EDC Systems
We seamlessly integrate our statistical programming services with various electronic data capture (EDC) systems, optimizing data flow and reducing errors
Comprehensive Reporting
We provide detailed and clear statistical reports and summaries that meet regulatory standards and support your decision-making processes
Our success based on how happy our clients are
As a full-service CRO, we specialize in clinical development, post-marketing,
and functional service support, ensuring your projects are managed with precision and integrity
Hira Technologies has been instrumental in the success of our clinical trials. Their expertise, responsiveness, and commitment to quality have kept our projects on track and within budget. Highly recommend for clinical development needs.”
Chief Medical Officer
Biopharma Company
Hira Technology’s post-marketing support has been crucial for our product’s success. Their proactive monitoring and detailed reports ensure compliance and inform our market strategy. Exceptional service and expertise.”
CRO
Pharma Company
Partnering with Hira Technologies for functional service support has streamlined our R&D operations. Their expert team integrates seamlessly with ours, delivering top-notch data management and biostatistics services. Outstanding professionalism.”
Head of R&D
Biotechnology Firm