PKPD / NONMEM
At Shafi Consultancy, we’ve been delivering high-quality NONMEM and WinNonLin ready datasets since 2001. With a dedicated team and decades of experience, we understand both the raw clinical data and the nuances of NONMEM requirements, ensuring timely, accurate delivery that supports confident decision-making. We also provide submission-ready ADPPK datasets, fully validated and aligned with regulatory standards.
What we deliver
Expert NONMEM-ready dataset creation and validation, ensuring timely, accurate delivery that supports confident decision-making.
Submission-ready ADPPK dataset, ensuring accuracy, reliability, and compliance with industry standards.
Comprehensive reporting, including covariate summaries, traceability documentation, and data issue logs.
Individual patient profiles for intuitive visual review and early identification of data anomalies.
Standardised templates and macros to ensure consistency across studies and accelerate project timelines.
The year we started delivering NONMEM and WinNonLin ready datasets.
We don’t just provide datasets — we deliver reliability. Every NONMEM-ready dataset is independently validated and checked for data integrity and accuracy. We also provide template specifications to ensure consistency across studies, and use robust, standardised macros to accelerate delivery timelines without compromising on quality.
Comprehensive Reporting & Traceability
Our NONMEM services are backed by detailed, value-added documentation that gives you full visibility into your data. We provide covariate summary reports, traceability documentation that links every record from raw source to final dataset, and individual patient profiles for intuitive visual review.
These reports help identify potential issues early and support thorough data understanding, enabling your team to proceed with confidence. Whether it’s a single study or part of a larger submission package, our clear, validated reporting ensures your NONMEM data is analysis-ready from day one.
Individual patient profiles
Illustrative data. One subject is flagged so a data anomaly is caught at review, not at analysis.
Frequently asked questions
What is a NONMEM-ready dataset?
It is a dataset prepared from clinical data in the structure NONMEM needs for population PK/PD analysis. We create it from the raw clinical data and independently validate it for integrity and accuracy.
What do you deliver alongside the dataset?
Alongside the dataset we provide covariate summary reports, traceability documentation linking each record from raw source to final dataset, data issue logs and individual patient profiles for visual review.
Do you provide submission-ready ADPPK datasets?
Yes. We provide ADPPK datasets that are fully validated and aligned with regulatory standards, as well as datasets ready for NONMEM and WinNonLin.
How is the quality of the datasets assured?
Every NONMEM-ready dataset is independently validated. We also use template specifications and standardised macros to keep studies consistent and speed up delivery without compromising quality.