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CDISC

At Shafi Consultancy, we specialise in delivering efficient, high-quality CDISC services. Our expert team has extensive experience in developing and validating SDTM and ADaM — compliant datasets, ensuring they are fully prepared for regulatory submission.

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We also meticulously prepare all the necessary documentation for regulatory submissions, including the Annotated CRF, Define.XML and Data Reviewer's Guides.

 

Every deliverable undergoes thorough quality control to ensure accuracy, consistency, and full alignment with industry standards — helping you meet submission requirements with confidence.

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Consultation with experts who have deep knowledge of CDISC standards and regulatory requirements.

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Development and validation of SDTM and ADaM  compliant datasets.

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Legacy data to SDTM conversion.

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End-to-end creation of submission documentation, including aCRF, Define.XML, Data Reviewer’s Guide.

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Rigorous quality control and data checking to ensure accuracy, consistency, and compliance.

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