Founder & Managing Director · Shafi Consultancy Ltd.
Bridging clinical rigour with advanced computational analytics.
Approximately 33 years in the pharmaceutical industry. Since founding Shafi Consultancy in 2001, Shafi has led a specialist clinical programming company serving pharmaceutical sponsors and CROs, from CDISC-standard data and TLF reporting to analysis-ready PK/PD datasets for NONMEM.
Clinical trials Statistics & clean data Advanced modelling
ScrollClinical trials Modelling
Two interactive models of the data Shafi's teams work with. Drag to rotate. Select a node or a point on the surface to read its values.
SDTM collected data and ADaM analysis data as two linked strands. Each rung is a traceability link between them.
SDTM · collected data
Node 2 of 52
AEAdverse Events
Traces to ADAE through STUDYID and USUBJID.
Simulated one-compartment oral model: plasma concentration across time and clearance, at three volume-of-distribution percentiles.
Median layer · V = 38 L
Dose 400 mg · KA 1.1 h⁻¹
TIME
2.3 h
CL
4.2 L/h
CONC.
—
Statistics & clean data
The kind of outputs statistical programmers produce at the end of a trial. The charts use simulated data and respond to hover and the controls.
Industry experience
33+
Years in the pharmaceutical industry
Founded
2001
Shafi Consultancy Ltd. established
Leadership
25
Years leading a specialist clinical programming company
Therapeutic window 2–8 mg/L
| At risk |
|---|
One-compartment oral model with first-order absorption, dosed every 12 hours for 7 days. Steady state is reached after about five half-lives.
Statistics · Reporting
Tables, listings and figures are the reviewed outputs of a clinical study. Switch between three typical outputs, generated here from simulated ADaM-style data.
Advanced modelling
Non-linear mixed-effects modelling estimates how drug exposure varies between patients. Analysis-ready NONMEM datasets and clinical pharmacology programming are a specialist service delivered under Shafi's leadership.
Dosing and observation rows with AMT, EVID, MDV and CMT, built from ADaM.
Weight, renal function and other subject-level covariates, merged and checked.
Goodness-of-fit plots such as observed against predicted concentrations.
| Parameter | Estimate | RSE |
|---|---|---|
| CL (L/h) | 4.18 | 4.6% |
| V (L) | 37.9 | 5.2% |
| KA (1/h) | 1.07 | 9.8% |
| Proportional error | 11.8% | 6.1% |
Simulated run: 40 subjects, 320 observations. Estimates are illustrative.
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Founder & Managing Director, Shafi Consultancy Ltd.
Shafi has spent approximately 33 years in the pharmaceutical industry, in roles spanning pharmaceutical operations, clinical research and clinical statistical programming. In 2001 he founded Shafi Consultancy Ltd., a specialist clinical programming company working with pharmaceutical companies and contract research organisations, where he continues to focus on quality, programming innovation and developing people.