MetaPool
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.
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.
Consultation with experts who have deep knowledge of CDISC standards and regulatory requirements.
Development and validation of SDTM and ADaM — compliant datasets.
Legacy data to SDTM conversion.
End-to-end creation of submission documentation, including aCRF, Define.XML, Data Reviewer’s Guide.
Rigorous quality control and data checking to ensure accuracy, consistency, and compliance.
Our
Approach
Combining experienced resources, proven processes, and specialised tools, we deliver high-quality, submission-ready outputs. From project initiation to final delivery, our expert team ensures efficiency, consistency, and compliance at every stage.
Resource and
Planning
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Our experts have complete CDISC domain knowledge and experience in different
therapeutic areas.
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Integrated project planner with the emphasis on Risk Management, Managing timelines and maintaining Good Programming Practices (GPP) throughout, ensures the projects run smoothly until completion.
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Traceability maintained in every aspect of Data Conversion.
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Staff stay current with the latest CDISC Implementation Guides and regulatory updates.
Tools and
Templates
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In-house developed SAS macros and template programs are utilised to streamline conversion and dataset production.
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Pinnacle 21 is used to ensure compliance with CDISC validation standards.
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Standardised tools enable consistency across projects and faster turnaround times.
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Continuous improvement of tools based on project experience and evolving industry best practices.
Assess and
Execute
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Well-defined SOPs, work instructions, and checklists guide every step.
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Structured workflows for efficient SDTM and ADaM package generation.
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Rigorous data checking to maintain integrity and accuracy of deliverables.
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Integrated validation and verification processes ensure quality and compliance.