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 in many therapeutic areas including Oncology, Respiratory, Infectious Diseases, Cardiovascular and Ophthalmology among others.
From raw clinical data to submission-ready deliverables
Every study follows the same traceable path, with independent quality control at each step.
We 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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Raw clinical data
EDC, labs, ECG, ePRO and legacy data arrive in many different shapes.
EDCLabsECG ePROPKLegacyData checked -
SDTM
Mapped to the standard domains, with specifications and issue tracking.
DMAELB VSEXCMQC checked -
ADaM
Analysis datasets derived with full traceability back to the source.
ADSLADAEADLBADTTEQC checked -
TLFs
Tables, listings and figures produced and independently validated.
Double programmed -
Submission-ready
Everything a reviewer needs, packaged for the regulator.
- aCRF
- Define.XML
- Data Reviewer’s Guide
What we deliver
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
- Our experts have complete CDISC domain knowledge and experience in different therapeutic areas.
- 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.
- Traceability maintained in every aspect of Data Conversion.
- Staff stay current with the latest CDISC Implementation Guides and regulatory updates.
Tools and Templates
- In-house developed SAS macros and template programs are utilised to streamline conversion and dataset production.
- Pinnacle 21 is used to ensure compliance with CDISC validation standards.
- Standardised tools enable consistency across projects and faster turnaround times.
- Continuous improvement of tools based on project experience and evolving industry best practices.
Assess and Execute
- Well-defined SOPs, work instructions, and checklists guide every step.
- Structured workflows for efficient SDTM and ADaM package generation.
- Rigorous data checking to maintain integrity and accuracy of deliverables.
- Integrated validation and verification processes ensure quality and compliance.
Frequently asked questions
What CDISC services do you provide?
We develop and validate SDTM and ADaM compliant datasets, convert legacy data to SDTM, and prepare submission documentation including the annotated CRF, Define.XML and Data Reviewer’s Guides.
Can you convert legacy data to SDTM?
Yes. Legacy data to SDTM conversion is part of our CDISC service, with traceability maintained in every aspect of the conversion.
How do you check CDISC compliance?
We use Pinnacle 21 to check compliance with CDISC validation standards, and independent quality control at each stage, guided by defined SOPs, work instructions and checklists.
Which therapeutic areas do you have experience in?
Our team has experience across many therapeutic areas, including oncology, respiratory, infectious diseases, cardiovascular and ophthalmology, among others.