Validation and QC
Independent Validation. Confidence in Every Deliverable.
Ensure the accuracy, consistency, and reliability of your clinical trial programming outputs with Shafi Consultancy’s independent validation and quality control (QC) services.
Our experienced statistical programmers perform independent double programming and systematic reviews of programs, outputs, specifications, and shells to help identify discrepancies before deliverables are finalised. We verify that tables, listings, figures (TLFs), and analysis datasets align with approved specifications and expected results.
Our validation and QC services include:
Independent Double Programming
Independently develop programs to verify results and identify potential discrepancies.
Program and Output Validation
Review statistical programs and generated outputs against specifications, shells, and expected results.
TLF Quality Control
Check tables, listings, and figures for accuracy, consistency, completeness, and presentation requirements.
Analysis Dataset QC
Review analysis datasets for consistency with programming specifications and applicable derivation requirements.
Discrepancy Reporting
Document identified issues clearly to support investigation, resolution, and revalidation.
With a quality-focused approach and extensive experience in clinical statistical programming, Shafi Consultancy helps pharmaceutical companies and CROs strengthen confidence in their programming deliverables and support reliable clinical trial reporting.
Frequently asked questions
What is independent double programming?
Independent double programming means a second programmer develops programs separately to verify the results of the production programs, so that any discrepancy is identified before deliverables are finalised.
What can you validate or quality check?
We review programs and outputs against specifications, shells and expected results, check tables, listings and figures (TLFs), and review analysis datasets against programming specifications and derivation requirements.
How are discrepancies reported?
Identified issues are documented clearly to support investigation, resolution and revalidation, so each discrepancy can be traced through to closure.
Who is this service for?
Pharmaceutical companies and CROs that want independent confidence in their clinical programming deliverables, whether for a single study or an ongoing programme.
Need independent QC or validation support for your next study?
Contact our team to discuss your project requirements.