Solutions
Governed AI solutions for life sciences teams. Each one states the problem it solves, what we build, and what you are left holding when the engagement closes.
Every solution ships with the same provenance standard, a defined validation test, and a governance tier agreed before work begins. That standard holds whoever does the building.
Who we serve
Drug development
Biotech and pharma teams in discovery, translational research, clinical development, and CMC.
Pressure point: Data arrives faster than a lean team can engineer it, ahead of a financing, a partnership, or a Phase 2 decision.
Medical devices
Device developers in design iteration, bench testing, and market access.
Pressure point: The cost of each physical test loop, or the evidence a hospital value committee will ask for before it buys.
Digital health and diagnostics
Companies deploying AI-enabled products into health systems.
Pressure point: Integration work that repeats at every new site, and proving real-world performance after authorization.
What we build
Governed AI solutions
We lead every engagement and partner with Innowise on the technical side. Governance, data handling, and the validation standard stay with us.
Research data foundation
One governed place to ask questions of your research data, connected through a shared scientific vocabulary.
The problem
Answering one focused research question means combining publications, trial records, omics, chemistry, protein annotations, and your own internal data. Each source uses different formats, identifiers, and naming. The same entity appears under different names, a broad disease category in one dataset is split into subtypes in another, and teams spend more time connecting information than analyzing it.
What we build
A governed data environment that brings the sources you need into one place and connects them through an ontology built around your scientific domain. Established biomedical resources are reused where they fit, local concepts are defined where they do not, and every mapping is reviewed. Layered storage keeps source data separate from analysis-ready sets, so a reviewer can trace any value back to where it came from.
What you get
A reusable foundation rather than another one-off extract, a searchable collection that does not depend on knowing each source's naming conventions, and documented transformation logic your team can audit.
Clinical and real-world evidence
Structured, defensible evidence from published research through to performance after authorization.
The problem
Getting usable evidence out of published research means reading each publication and transferring results into extraction forms by hand, and studies describe populations and outcomes differently. After authorization the questions change: value committees and payers ask about length of stay, readmissions, complications, and cost in their own populations, not a trial population.
What we build
AI-assisted extraction into a structured schema covering population, intervention, comparator, outcomes, design, and results, with reviewers checking each record against the source text. For products in the market, cohort and outcome definitions, claims and patient-reported outcome linkage, and health economics analysis built on them, plus real-world performance monitoring where a deployed model is involved.
What you get
An evidence base that answers the next question without another manual search, evidence tables ready for synthesis or assessment, and a value dossier a purchasing committee can act on.
Clinical systems integration
Connect to the systems where clinical data already lives, in the formats those systems actually speak.
The problem
Every new hospital adds integration work, and that work rarely transfers to the next site. Trial systems and hospital record systems do not share a language. Much of what matters clinically sits in free-text notes that no structured query reaches.
What we build
Reusable connectors to electronic health records, laboratory and imaging systems, and payers, using FHIR and HL7. Trial data moves out in FHIR and clinical data back in CDISC CDASH. Language model pipelines extract structure from clinical notes.
What you get
Site rollouts that get faster rather than staying constant, a documented mapping specification, and a transfer log that holds up in an audit.
In silico modeling and digital twins
Computational models that answer a specific development question before, or alongside, physical testing.
The problem
Physical experiments and bench tests are slow and expensive, and each one validates a narrow set of conditions. A device does not behave the way its nominal design predicts once it meets real anatomy. Computational evidence only carries weight when the model's scope, inputs, and credibility are documented.
What we build
Models scoped to one question. For medical devices, digital twins covering structural deformation, fluid dynamics, or heat transfer, with anatomy from imaging, geometry from CAD, and predictions compared against reserved physical observations. Every parameter is recorded with its origin.
What you get
Quantitative comparison across designs, materials, and patient anatomies under controlled conditions, the specific places physical testing should now focus, and a credibility record you can put in front of a reviewer.
Process development and design of experiments
Experimental discipline on a live manufacturing campaign, without sending process IP to a public model.
The problem
Manufacturing parameters are coupled, quality attributes compete with each other, and the run budget is limited. Teams need experimental discipline quickly, and cannot send process IP to a public model to get it.
What we build
An evidence-graded constraint map and a sequential design of experiments that adapts as runs generate data. Every constraint tagged by source. Multi-response trade-offs settled by a scoring rule agreed before the first run.
What you get
More information per run, trade-offs resolved by rule, and artifacts that feed directly into quality-by-design and regulatory documentation.
Regulatory and quality workflows
AI-assisted drafting, trial documentation, and investigation support, with a named reviewer on every output.
The problem
Producing clinical and preclinical documents is slow and repetitive. Trial master file gaps surface late, usually when a submission is being assembled. Investigations start with assembling a record that lives across several systems.
What we build
Drafting support grounded in your own source data and templates. Continuous monitoring of trial documentation against a structured model, with notification when a completeness test fails. Investigation support that assembles the event record and proposes causes with evidence attached.
What you get
Faster first drafts, gaps found while the trial is running rather than at submission, and a provenance record on each AI-assisted section.
AI governance readiness review
An independent read on whether your AI story survives diligence, before someone else performs that read for you.
The problem
Boards, partners, and acquirers now probe how AI is used. Tools adopted ad hoc, unclear data lineage, and an AI narrative with no governance underneath read as risk at exactly the moment a company wants to look like an asset.
What we build
A structured review of where AI is already in use, what data it touches, what governance exists, and where the gaps sit against the standards your buyers and auditors will apply.
What you get
A clear statement of your current position, a ranked list of what to fix, and an AI story you can defend in a room full of people paid to find holes in it.
For investors and operating partners. The governance readiness review also runs across a portfolio, giving a fund one consistent view of AI readiness before financings and exits rather than a different answer from each company.
Fit
Which solutions fit which segment
| Solution | Drug development | Medical devices | Digital health |
|---|
| Research data foundation | High | Medium | High |
| Clinical and real-world evidence | High | High | High |
| Clinical systems integration | Medium | Selective | High |
| In silico modeling and digital twins | — | High | — |
| Process development and DOE | High | Selective | — |
| Regulatory and quality workflows | High | Medium | Medium |
| AI governance readiness review | High | High | High |
How engagements run
Engagements start small and earn the next step
Diagnose
Led by us · 2 to 3 weeks
Pick the use case with the clearest value, set the data boundary, agree the governance tier, and define the test of success in writing.
Pilot
Joint · 8 to 12 weeks
One scoped build, provenance on every output, and a pass or fail against the test agreed in stage one.
Scale
Joint · ongoing
Extend to adjacent programs and functions. The governance carries forward. The team is sized to the roadmap rather than to a contract.
If the pilot fails its test, we say so. That is what the test is for.
How we deliver
We keep our own team small and senior. Where an engagement needs engineering capacity at scale, we bring it in through Innowise, our technical solutions partner, whose life sciences practice covers data and machine learning engineering, bioinformatics, cheminformatics, and biocuration. We can also place scoped specialist teams of data and machine learning engineers, bioinformaticians, and biocurators inside your organization, working to the same provenance and validation standard as the rest of our work. Governance, data handling, and the validation standard stay with us in every case. Every deliverable ships with the same provenance record and the same validation test, whoever built it.