Auditing

Ensuring Statistical Programming Excellence

At Metadata, we understand that statistical programming integrity is critical to the success of clinical trials. Regulatory agencies expect programming deliverables to be accurate, transparent, and compliant, yet many biotech and pharmaceutical companies lack independent oversight of their CRO’s programming outputs.

Our Statistical Programming Audit provides an independent, comprehensive review of your programming processes, ensuring they meet industry best practices, regulatory expectations, and your own internal standards.

Each audit is structured as a collaborative project, allowing us to identify risks, inefficiencies, and gaps before they become costly issues.

SOP & Process Compliance Review

A robust set of Standard Operating Procedures (SOPs) should be clear, practical, and consistently applied across all statistical programming activities. We review:

✔ Usability & Practicality - Are your SOPs written in a way that your team can easily follow and implement?
✔ Consistency & Alignment - Do different teams interpret and apply them in the same way?
✔ Regulatory Gap Analysis - Are there missing elements that could cause compliance issues?

By assessing these areas, we help ensure your SOPs are fit for purpose and provide clear guidance without unnecessary complexity.

Programming Standards & Regulatory Alignment

Statistical programming shouldn’t just be functional - it should be compliant, efficient, and future-proof. We assess whether:

✔ Your programming standards align with current regulatory expectations (e.g., CDISC, FDA, EMA, MHRA).
✔ Best programming practices are consistently followed.
✔ Inefficiencies exist - can certain processes be streamlined?
✔ Common pitfalls (e.g., version control issues, outdated methodologies) are present.

If standards are outdated, inconsistently applied, or missing key components, we provide actionable recommendations to align them with industry best practices.

Programming Quality & Code Review

Beyond compliance, programming should be clear, maintainable, and adaptable. We evaluate:

✔ Code readability & structure – Are the programs easy to follow and modify when needed?
✔ Good programming practices – Is the code modular, well-commented, and reusable?
✔ Hardcoding risks – Are there non-dynamic elements that could cause inconsistencies?
✔ SOP Adherence – Do programs follow the organisation’s own SOPs and programming standards?

We provide feedback on optimisation, consistency, and quality, ensuring that future programmers or auditors can easily understand and maintain the work.

Deliverable Completeness & Regulatory Readiness

A common issue in clinical trials is that deliverables appear complete but are missing key components that regulators expect. We assess:

✔ Are all required programming deliverables included?
✔ Likelihood of regulatory rejection - Are elements missing that could delay approval?
✔ Data traceability & documentation - Are the datasets and outputs well-documented and easily reproducible?

By identifying gaps before submission, we help sponsors reduce regulatory risks and avoid costly last-minute fixes.

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