FGK’s CDISC compliance

What is CDISC?

The Clinical Data Interchange Standards Consortium (CDISC), a global non-profit organization, develops data standards to streamline the exchange of clinical research data.

CDISC compliance of trial datasets is essential to meet certain regulatory requirements, facilitate data sharing and collaboration, and promote interoperability and data reuse.

Benefits of standardized datasets:

  • When CDISC data standards are implemented, high-quality, interpretable data can be exchanged easily and efficiently between sponsor and regulatory agencies. Furthermore, pooling of studies is facilitated.
  • Implementing CDISC standards  accelerates regulatory processes, resulting in faster marketing authorization.

When is CDISC Standard a Must Have?

CDISC’s primary goal is to improve medical research by standardizing data. Standardized data became a compulsory FDA (Food and Drug Administration) and PMDA (Pharmaceuticals and Medical Devices Agency) requirement for the submission of all clinical trial data. Regulatory agencies such as Chinese National Medical Products Administration (NMPA) recommend CDISC standards for regulatory submission of clinical trial data. Compliance with CDISC standards facilitates the review process by regulatory agencies, speeding up approval timelines for new drugs and medical devices.

Unlock the Power of CDISC Compliance with FGK`s Comprehensive Services

FGK supports you in incorporating SDTM and ADaM standards into your new trials and can convert previous trial data into CDISC compliant datasets.

Why Choose FGK for CDISC Services?

At FGK, we understand that converting clinical trial data into a standardized format can be a complex and time-consuming process. That's why we offer a range of expert CDISC SDTM services to streamline your submission processes.

FGK`s data managers and statisticians can offer in-depth knowledge in CDISC standards to provide SDTM and ADaM programming and documentation:

  1. CDISC Expertise: Our teams of experienced professionals include CDISC experts who are well-versed in the SDTM and ADaM standards. We ensure that your data is compliant and ready for regulatory submissions. Our skilled teams have been utilizing CDISC standards for over 10 years and keep track of any new development.
  2. Efficient Data Conversion: We excel in transforming raw clinical data into CDISC SDTM datasets efficiently, reducing the time and effort required for this critical step in the drug development lifecycle.
  3. Analysis Ready Datasets: Traceability from CRF to CSR: with the creation of ADaM domains we assure high quality results where every step is comprehensible.
  4. Quality Assurance: Quality is at the core of everything we do. We have rigorous quality control processes in place to ensure the accuracy and consistency of your CDISC datasets.
  5. Customized Solutions: We understand that every clinical trial is unique. Our services are tailored to meet your specific needs, whether you're a pharmaceutical or biotech company.
  6. Regulatory Compliance: We stay up-to-date with the latest regulatory requirements to ensure that your CDISC datasets are submission-ready and compliant with global standards.

Our CDISC SDTM and ADaM Services Include:

  • Data Mapping and Transformation: We map your data to SDTM domains, transforming it into the required format while maintaining data integrity.
  • SDTM Creation: We create SDTM datasets for all relevant domains.
  • ADaM Creation: Based on the SDTM data we develop ADaM datasets for the creation of analysis results to assure traceability of all results.
  • Annotation and Metadata: We provide comprehensive annotation and metadata to make your CDISC datasets understandable and usable.
  • Validation and QC: Our team conducts thorough validation and quality control checks to ensure the accuracy and compliance of your CDISC datasets. We assure the regulatory requirements by validating SDTM and ADaM datasets using Pinnacle 21.
  • Complete submission packages: We produce high quality, submission-ready CDISC datasets and the associated documentation (including define.xml, SDTM and ADaM reviewer’s guides) for regulatory agencies.
  • ISS/ISE: We offer the preparation of SDTM and/or ADaM datasets for your ISS/ISE submission.
  • Custom Solutions: If you have specific requirements or need additional services, we can tailor our offerings to suit your project's unique needs.