SDTM Programming
We ensure seamless conversion of clinical trial data into standardized SDTM format, meeting CDISC requirements for regulatory submissions. Our experienced programmers bring deep knowledge of CDISC standards, ensuring data integrity and compliance. From mapping raw data to creating define.xml files, we streamline the process, enhancing the efficiency of your submissions. Trust our expertise to deliver accurate, high-quality datasets that facilitate smoother regulatory reviews and successful trial outcomes
What we do?
Our expertise ensures precise, reliable data that guides your product from early stages to post-approval
SDTM Dataset Creation
Transform raw clinical data into standardized SDTM datasets. Our team ensures accuracy, consistency, and compliance with CDISC standards, facilitating efficient data review and regulatory submission
Quality Control and Validation
Implement rigorous quality control and validation processes to ensure the accuracy and completeness of SDTM datasets. Our validation protocols meet regulatory expectations, minimizing the risk of submission delays
Regulatory Submission Support
Prepare and review SDTM datasets for regulatory submissions, ensuring they meet the stringent requirements of agencies like the FDA and EMA. We provide comprehensive support for a smooth submission process
Data Integration and Standardization
Integrate and standardize data from multiple sources and studies into a cohesive SDTM format. Our expertise ensures consistency and facilitates cross-study comparisons and meta-analyses
Automated SDTM Generation
Utilize advanced automation tools and scripts to generate SDTM datasets efficiently. Our automated processes reduce manual effort, enhance accuracy, and speed up the data preparation timeline
Training and Consultation
Offer training and consultation services to enhance your team’s understanding of SDTM standards and practices. Our experts provide guidance on best practices, regulatory requirements, and efficient data management strategies
Our Differentiators
Our expertise ensures precise, reliable data that guides your product from early stages to post-approval
Expert Team
Our team consists of seasoned SDTM programmers and data managers who bring deep industry knowledge and technical proficiency to every project
Customized Solutions
Utilize state-of-the-art automation tools and custom scripts to expedite SDTM dataset generation, reducing manual errors and increasing efficiency
Comprehensive Quality Control
Implement multi-layered quality control processes to ensure data accuracy, completeness, and consistency, minimizing the risk of submission rejections
Seamless Integration
Expertise in integrating data from various sources, including EDC systems, lab data, and legacy databases, into a unified SDTM format
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