The software is not the deliverable. The evidence is.
In a validated estate, a working system that cannot be evidenced is not a system you can use. That single fact reshapes how everything gets built — which is why the highest-return work in most life sciences organizations is automating the evidence rather than adding features.
Partnering in the work of bringing science to patients
Across life sciences you find people developing therapies, devices, and diagnostics for conditions that have waited decades for one. That work carries obligations most industries never face — every result traceable, every change justified, every system able to demonstrate it does what it claims.
Alongside them you find our practitioners: the engineers, validation specialists, and platform consultants who build and qualify the systems that carry clinical, regulatory, quality, and manufacturing work. We bring deep sector experience, technology that is designed for scrutiny rather than adapted to it, and the discipline to make evidence a byproduct of delivery instead of the reason it waits.
From first study to commercial supply.
Each stands alone as an engagement. Most programmes start where the regulatory burden is heaviest, because that is where automation returns the most. AI has its own section below.
Clinical Trial Data Systems
Where the timeline is actually won or lost.
EDC, CTMS, and IRT integration, plus the data flows between sponsor, site, and CRO that decide whether database lock happens on schedule. Most trial delays that get blamed on recruitment are really reconciliation problems nobody scoped.
Regulatory Submission Systems
Traceable from source to filing.
Document management, eCTD assembly, and the lineage that lets you answer where a number in a submission came from without a two-week search.
Computer System Validation & GxP
Validation as an output, not a phase.
Automated pipelines that generate IQ/OQ/PQ evidence as software is built, so a validated environment stops being the reason releases take a quarter. This is the single change that most alters delivery economics in a GxP estate.
Laboratory Systems Integration
Instruments, LIMS, and the gap between.
LIMS and ELN integration, instrument data capture, and the sample lifecycle that currently depends on someone re-keying results.
Manufacturing & Supply Chain
From batch record to serialized pack.
MES and ERP integration, electronic batch records, serialization, and the track-and-trace obligations that vary by every market you ship into.
R&D Data Platforms
Findable, reusable research data.
Governed platforms across assay, omics, and study data so results from three years ago can still be located and trusted.
Pharmacovigilance & Safety
Case volume that keeps growing.
Intake, triage, and narrative drafting for adverse event processing, with the audit trail regulators expect and human review retained where it matters.
Connected Devices & SaMD
Software inside a regulated product.
Device connectivity, fleet telemetry, and software engineering under design controls, where every change is treated as a risk event by the submission process.
Modernization in Validated Estates
The system that survived three mergers.
Incremental modernization inside validated environments, with characterization tests and revalidation planned rather than discovered late.
Where AI holds up under inspection.
In a regulated estate, an AI system you cannot explain is an AI system you cannot use. These five work because a qualified person stays on the approval path and the evidence is generated alongside the output.
Scientific Literature & Evidence Synthesis
Where the literature is too large to read.
Synthesis across publications, trial registries, and internal study reports with every claim traced to its source. The volume of relevant evidence now exceeds what any team can review manually, which is exactly the condition retrieval systems were built for.
Regulatory Document Drafting
First drafts from approved source material.
Protocol sections, clinical study reports, and submission narratives assembled from validated inputs, with medical writers reviewing and owning the output.
Safety Signal Triage
Case volume that keeps outgrowing headcount.
Duplicate detection, seriousness assessment support, and narrative drafting across adverse event intake, with a qualified person deciding every case.
Trial Data Quality Models
Catch the discrepancy before it becomes a query.
Anomaly detection across EDC, lab, and IRT data that surfaces inconsistencies while a site can still resolve them, rather than at lock.
GxP AI Validation & Governance
Validating a system that is not deterministic.
Model inventories, intended-use documentation, accuracy and drift evidence, and the validation approach for AI in a regulated workflow — the question inspectors have started asking.
The platforms that run regulated operations.
Standing practices on each, staffed by people who have implemented and validated these systems inside regulated environments.
Veeva Vault
Vault RIM, Quality, and Clinical — implementation, migration, and the integration work that connects Vault to the systems either side of it.
ValGenesis
Digital validation lifecycle management — implementation and integration so validation evidence is generated in the system rather than assembled around it.
SAP
S/4HANA for manufacturing, supply chain, and serialization, including the batch record and quality integrations a regulated estate depends on.
Four categories, four different clocks.
A biotech races a patent, a CRO serves someone else's timeline, and a manufacturer cannot stop the line. Select yours.
Pharmaceuticals & Biotech
Patent clocks make time the expensive resource. Anything that shortens the path from data collection to a defensible decision pays back faster here than cost reduction ever will.
Bring us the system that keeps slipping.
The validation cycle that adds a quarter to every release. The reconciliation between trial systems that surfaces at lock. The submission trail that takes a fortnight to reconstruct. Tell us which one and we will tell you what a first engagement would cover — and what we would leave alone.