CDISC
Standardizing Clinical Data for Seamless Regulatory Submissions
At Yonex Pharma, we specialize in CDISC (Clinical Data Interchange Standards Consortium) standards to ensure that your clinical trial data meets global regulatory requirements and is ready for submission to regulatory authorities like the FDA, EMA, and others. Our CDISC services help streamline the process of data submission by converting your clinical trial data into standardized formats that enhance data consistency, transparency, and efficiency. With our expertise, we ensure your clinical data is fully compliant with CDISC standards and ready for successful regulatory review.
Our CDISC Services
CDISC standards are essential for any clinical development program, ensuring that your data is structured, validated, and compliant with global regulations. Yonex Pharma offers a comprehensive range of CDISC services to guide you through every stage of clinical data management, from collection to submission.
Our CDISC Service Offerings
SDTM (Study Data Tabulation Model)
We transform your clinical trial data into the SDTM format, which is required by regulatory authorities for data submission. Our team ensures that your data is mapped correctly, validated, and fully compliant with SDTM standards.
ADaM (Analysis Data Model)
We specialize in converting clinical trial data into the ADaM format, which is designed for statistical analysis. Our CDISC services ensure that your datasets are ready for statistical analysis and can be easily integrated into regulatory submission packages.
Define.XML
We assist in creating the Define.XML files, which provide metadata for your datasets in a standardized format. This is essential for regulatory agencies to understand the structure of your clinical trial data. Our team ensures that your Define.XML files are precise and compliant with the latest CDISC guidelines.
CDISC Compliance and Validation
We offer comprehensive compliance checks and validation services to ensure that your data is fully compliant with CDISC standards. Our team performs thorough reviews and validations of your datasets, ensuring they are ready for submission to regulatory bodies.
CDISC Training and Consultation
We provide expert training and consultation services to help your team understand CDISC standards and best practices. Whether you need assistance with SDTM, ADaM, or Define.XML, we offer tailored training solutions to meet your needs.
Why Choose Yonex Pharma for CDISC Services?
Expertise in CDISC Standards
Regulatory Knowledge
End-to-End CDISC Support
How We Work
Initial Consultation
We begin by understanding your clinical trial's data requirements and CDISC needs. Our team will collaborate with you to define the best approach for converting your clinical data to CDISC-compliant formats.
Data Conversion and Mapping
We perform the necessary data conversion and mapping, ensuring that your trial data is accurately transformed into SDTM, ADaM, and Define.XML formats in line with CDISC standards.
Validation and Compliance Review
Once the data is converted, we conduct thorough validation checks to ensure full compliance with CDISC standards. This step ensures that your data is free from errors and ready for regulatory submission.
Submission-Ready Documentation
We prepare and finalize all necessary documentation, including SDTM, ADaM datasets, and Define.XML files, ensuring they are submission-ready for global regulatory authorities.
Ensure Global Compliance with Yonex Pharma’s CDISC Services
At Yonex Pharma, we understand that meeting the stringent requirements for clinical data submission can be a complex and time-consuming process. Our CDISC services are designed to simplify this process, ensuring your clinical trial data is fully compliant with global regulatory standards and ready for successful submission. Trust us to guide you through every step of the CDISC journey, from data conversion to final regulatory review.
Ensure your clinical data is CDISC-compliant and ready for regulatory submission with Yonex Pharma’s expert services. Our team is here to help you meet all regulatory requirements and achieve a successful outcome for your clinical development program.