CDISC Data Standards Implementation – SDTM

Comprehensive CDISC SDTM Standards Implementation Services

Data standardization into SDTM Standards enhances the overall quality of clinical data and streamlines the review process by regulatory authorities.

As a CDISC Registered Solutions Provider, we offer professional expertise in converting clinical data to CDISC SDTM standards, ensuring regulatory compliance and efficient data handling.

Almustat MAKES SURE YOUR DATA ARE READY FOR SUBMISSION.

All pivotal studies conducted by Almustat are designed to meet FDA electronic submission requirements. To achieve this, we transform database structures into SDTM format, complete with the appropriate supporting documentation.
Our SDTM experts are skilled in developing eCRFs according to CDASH standards and delivering data in SDTM format. The SDTM datasets are generated using the latest CDISC model available at the start of the process. Additionally, Almustat has the expertise to perform thorough quality control and verification of existing packages to ensure they are ready for submission.
Our EDC system is fully compliant with ODM standards, ensuring consistency and regulatory adherence throughout the data management process.

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SDTM Standards Package

Our SDTM Services include:
- Mapping to SDTM Standards: Ensuring your clinical trial data aligns with SDTM standards for regulatory compliance.
- SDTM Annotated CRFs: Developing annotated Case Report Forms (CRFs) to align with SDTM requirements.
- .xpt File Generation: Creating .xpt files for FDA submissions.
- XML and define.pdf Creation: Generating xml and define.pdf files from SDTM dataset definitions to provide metadata documentation.
- Data Validation and define.xml Files: Conducting validation of data and associated define.xml files for accuracy.
- Creation of Clinical Study Data Reviewer’s Guide (cSDRG): Developing a comprehensive guide for clinical data reviewers.
- Support for Integrated Summaries of Safety & Efficacy (ISS/ISE): Using SDTM formats to facilitate the pooling of clinical trials for integrated safety and efficacy summaries.
These services ensure your clinical data is well-documented, compliant, and ready for regulatory submission.

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CDISC Data Standards Implementation – SDTM

Comprehensive CDISC SDTM Standards Implementation Services

Almustat MAKES SURE YOUR DATA ARE READY FOR SUBMISSION.

SDTM Standards Package

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