Clinical Data Standards
The Importance of CDISC Standards in Regulatory Submissions
In 2013, the FDA emphasized the critical role of standardized study data, highlighting its ability to enhance reviewers' understanding of a medical product's efficacy and safety. By 2014, the FDA finalized binding guidance, mandating the submission of electronic data in a standardized format for efficient processing, review, and archiving.
By the end of 2016, both the FDA and PMDA made CDISC standards mandatory for all submissions. Non-compliant submissions after this deadline risked receiving a Refusal to File (RTF). As a result, all studies initiated in 2017 or later must submit data to the FDA in an electronic format adhering to CDISC standards, ensuring compliance and facilitating smoother regulatory reviews.
Services We Offer
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Comprehensive Data Standards Library
Our Data Standards Library provides a centralized repository of standardized data definitions, formats, and guidelines, ensuring consistency, compliance, and efficiency across clinical trials. This resource supports seamless data integration, regulatory submissions, and streamlined study processes.
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Seamless Data Migration Projects to CDISC Standards
We specialize in efficient data migration projects, transforming legacy data into CDISC-compliant formats. Our expertise ensures accurate, standardized, and regulatory-ready data, supporting seamless submissions and enhancing the overall quality of your clinical trials.
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Precise Standard Mapping for Data Consistency
We provide expert standard mapping services to align your clinical trial data with CDISC and other regulatory requirements. Our meticulous approach ensures data consistency, compliance, and seamless integration, supporting accurate analysis and successful submissions.
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Expert Programming Services for Clinical Trials
We deliver high-quality programming services tailored to your clinical trial needs, including data analysis, reporting, and CDISC-compliant submissions. Our skilled team ensures accuracy, efficiency, and regulatory compliance, supporting the success of your studies.
ERIC’s CDISC Expertise
At ERIC, we understand that implementing data standards from the outset is crucial for seamless data mapping between sponsors, clients, and regulatory agencies. Since our inception, we have been providing clinical data standardization services to our healthcare partners, ensuring compliance with industry best practices.
Our team of expert programmers specializes in all aspects of clinical trial data generation and management. We ensure precise interpretation and implementation of the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM)—ensuring they are accurately documented, managed, and consistently applied. More importantly, we facilitate clear communication of these data standards to sponsors.
With extensive experience in CDISC SDTM & ADaM conversion, we execute projects efficiently while maintaining the highest quality standards. Our structured processes not only enhance data integrity and regulatory compliance but also drive cost efficiency for our clients.
"Optimize your clinical trial data with ERIC’s CDISC expertise—ensuring accuracy, compliance, and streamlined data submissions."
