Domino unveils automated QC to streamline biostatistics review

Domino Data Lab has unveiled Domino SCE QC, a capability that automates quality control processes within the statistical computing environment used by biostatistics and statistical programming teams in the life sciences sector. The solution introduces end-to-end traceability and embedded audit-readiness, aiming to streamline regulatory submission preparation and reduce the administrative burden associated with manual quality control tracking.

Embedded workflows

Domino SCE QC integrates directly with scientists' existing statistical computing environments. The new offering allows users to create, assign, and approve deliverables such as datasets, code files, and outputs within the SCE itself. Each item is automatically linked and version-controlled, which enables dual-programmer validation and automates tracking in line with regulatory expectations including the requirements of 21 CFR Part 11.

The centralisation of quality control tracking within the SCE means that all analytical work is recorded in a single place. Organisations can monitor review progress and approval status without resorting to disconnected or manual documentation processes, helping teams ensure compliance without introducing additional tools or process complexity.

Regulatory compliance

Regulatory compliance and audit preparedness present ongoing challenges for biopharmaceutical organisations, particularly as the scale and complexity of clinical analyses increase. Domino SCE QC seeks to address these demands by enforcing proper sequencing of reviews, automating documentation, and reducing the risk of duplicate work. Companies gain a structured record of decision-making and approvals that can be referenced throughout clinical submissions or in the case of audits.

The software also supports dual-programmer review workflows to ensure complete traceability of programming steps, reducing operational risks associated with human error or miscommunication during manual review cycles.

Industry collaboration

The product has been developed in collaboration with pharmaceutical industry partners and members of the SCE Coalition. According to Domino Data Lab, the development process was informed heavily by established workflows and documentation standards within GxP environments.

"Domino SCE QC represents the next step in modernising statistical programming. It gives life sciences organisations the ability to accelerate clinical analyses while maintaining full traceability and compliance, turning quality control into an integrated, automated part of the programming workflow," said Nick Elprin, CEO and co-founder, Domino Data Lab.

Scaling data practices

Domino SCE QC builds on the company's overall strategy to unify analytics infrastructure and review processes across teams. The approach seeks to reduce inconsistency and manual steps inherent in existing review cycles. Integrating quality control directly within the statistical programming environment aims to shorten regulatory submission timelines and enable clinical programming teams to work with increased oversight.

"With SCE QC, we're helping clinical programming teams eliminate manual QC tracking and get full visibility into review progress. Embedding quality oversight directly into the SCE shortens submission timelines and helps organisations be fully prepared for audits," said Chris McSpiritt, Vice President of Life Sciences Strategy, Domino Data Lab.