CDSIC Services
Our seasoned team specializes in transforming raw clinical data into CDISC-compliant formats, including SDTM and ADaM datasets, facilitating seamless regulatory submissions and data integration. We offer comprehensive solutions from data mapping and conversion to validation and quality control, ensuring consistency and accuracy. Our deep understanding of CDISC standards and guidelines helps streamline your clinical trial processes, enhance data integrity, and accelerate approval timelines. Trust us to deliver precise, compliant, and reliable CDISC services that support your clinical development goals
What we do?
Our expertise ensures precise, reliable data that guides your product from early stages to post-approval
Data Mapping and Transformation
Expertly map and transform diverse clinical data sources into CDISC-compliant formats, maintaining data integrity throughout the process
Quality Control and Validation
Implement rigorous quality control and validation procedures to ensure the accuracy and completeness of CDISC datasets, minimizing submission risks
Regulatory Submission Support
Prepare and review CDISC datasets for regulatory submissions, ensuring compliance with FDA, EMA, and other global standards for a smooth approval process
Custom CDISC Solutions
Develop customized CDISC solutions tailored to your study’s specific needs, from complex data structures to bespoke dataset requirements
Quality Assurance
QA professionals implement quality management systems, ensuring adherence to GCP and regulatory standards, mitigating risks and enhancing trial credibility
Training and Consultation
Provide training and consultation to enhance your team’s understanding of CDISC standards and best practices, improving overall data management capabilities
Our Differentiators
Our expertise ensures precise, reliable data that guides your product from early stages to post-approval
Customized Solutions
Tailored CDISC solutions to meet the unique needs of each clinical study, from simple trials to complex, multi-center projects
Robust Quality Control
Multi-layered quality control processes ensure the highest data accuracy, consistency, and integrity, reducing the risk of errors
End-to-End Solutions
Comprehensive CDISC services covering the entire clinical data lifecycle, from early development to post-marketing, ensuring consistent and reliable data management
Training and Support
Provide thorough training and continuous support to your team, enhancing their proficiency in CDISC standards and best practices
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