Corentis

Life Sciences

Governed AI for bounded life sciences workflows

Life sciences teams work in environments where rigour, traceability, and careful review matter. Corentis helps organisations introduce AI into selected operational workflows with testing, oversight, and evidence around the process.

Researchers working in a clinical laboratory

Where The Value Lies

Useful AI still needs review, traceability, and evidence

Life sciences organisations are under pressure to use AI in practical operational work, but the value only lands when the surrounding process remains bounded, reviewable, and suitable for regulated environments.

$60bn-$110bn

annual gen-AI value potential

McKinsey estimates generative AI could create significant annual value across pharma and medical products, with R&D and clinical development among the areas of interest.

The adoption pressure is real, but life sciences teams need controlled workflows rather than broad automation promises.

Source: McKinsey, generative AI in pharma

57%

of protocols had a substantial amendment

Tufts CSDD research found substantial protocol amendments were common, and nearly half were deemed avoidable by sponsors.

Better structure around review, escalation, and evidence can reduce friction when operational changes need to be understood later.

Source: Tufts CSDD protocol amendment analysis

$141k-$535k

median direct amendment cost

The same Tufts CSDD analysis reported median direct costs of $141k for Phase II and $535k for Phase III substantial amendments.

Corentis does not prevent protocol change, but it can help teams keep operational review, sign-off, and evidence clearer around bounded workflows.

Source: Tufts CSDD protocol amendment analysis

Audit trails

must stay interpretable

ICH E6(R3) data-governance guidance emphasises traceability, metadata, review of audit trails, and documented processes across the data lifecycle.

That is the environment Corentis is designed for: AI-supported work with visible controls, human review, and evidence that can be inspected.

Source: ICH E6(R3) Step 4 final guideline

Who It Is For

Operational teams that need support without losing process discipline

Corentis is aimed at teams working around regulated operational workflows, including document-heavy review processes, governance functions, QA-linked activities, and other bounded areas where oversight matters.

Trial document review

Support document-heavy operational review with clearer visibility, stronger controls, and audit-friendly outputs.

Protocol-deviation triage

Help teams organise and assess deviation-related information while preserving human review and sign-off.

Safety-case summarisation support

Support bounded summarisation workflows with oversight, review steps, and evidence around the process.

What Corentis Is For

Corentis is designed for operational and governance support around regulated workflows. It is not presented as a diagnostic or treatment tool.

Its purpose is to help organisations introduce AI into selected processes in a way that is easier to monitor, review, and evidence over time.

Why This Matters

In life sciences operations, the question is not simply whether AI can save time. The deeper question is whether the surrounding process remains transparent, reviewable, and appropriate for a regulated environment.

Corentis helps teams build that surrounding structure so operational gains do not come at the cost of confidence.

What Corentis Is

  • A governance layer for bounded operational AI workflows
  • A way to add review discipline, sign-off steps, and evidence generation around document-heavy processes
  • A platform intended to support operational oversight rather than replace regulated scientific judgement

What Corentis Is Not

  • Not a diagnostic product
  • Not a treatment system or clinical decision replacement
  • Not a claim that sensitive regulated workflows should run without human sign-off

Bounded Workflow View

A deliberate operational shape for life sciences oversight

This prototype-style module is intended to show bounded workflow support rather than broad automation claims.

Non-diagnostic product direction

Intake

Bounded

Operational material enters review

Documents, deviations, or summarisation inputs are gathered in a workflow that still expects oversight.

Controls

Governed

Checks sit around the process

Completeness checks, sign-off requirements, and escalation rules are attached before outputs are relied on.

Review

Required

Human sign-off stays visible

Named reviewers remain central wherever the workflow crosses a threshold or requires judgement.

Evidence

Retained

Record remains after the event

Approval history, exceptions, and supporting materials are preserved to support later review.

Prototype event trail

Intended to show the kind of reviewable workflow state Corentis is being built to expose.

Illustrative output

01

Deviation material structured for review rather than auto-actioned

02

Named reviewer sign-off recorded before workflow progresses

03

Evidence retained for QA and governance inspection

Detailed Example

Protocol-deviation triage with human sign-off

A practical starting point is protocol-deviation triage: a bounded operational workflow where AI may help organise information, but human judgement and review remain central.

Non-diagnostic example
01

Step 1

Workflow trigger

Deviation-related information is gathered and an AI-supported process helps structure, summarise, or classify the material for review.

02

Step 2

Controls and oversight

Corentis applies workflow rules around required checks, completeness, escalation conditions, and who must review outputs before they are relied on.

03

Step 3

Human sign-off

Named reviewers assess the output, approve it, request changes, or escalate it when the workflow crosses defined thresholds.

04

Step 4

Evidence generation

The workflow retains approval history, exceptions, and supporting materials so teams have a clearer record of what happened around the process.

What Corentis Adds

Product direction
  • bounded operational use rather than diagnostic or treatment positioning
  • review support for QA, governance, and operations teams
  • clearer sign-off and escalation discipline
  • evidence that can support regulated review processes

Review snapshot

01

Policy checks attached

02

Named review gate visible

03

Evidence ready for export

Bounded Adoption

Why careful scope is a strength

Overstated AI positioning

  • blurs the line between operational support and regulated judgement
  • creates uncertainty about who remains accountable
  • makes cautious teams less likely to adopt

Corentis approach

  • focuses on bounded operational workflows
  • keeps human sign-off visible in the process
  • makes oversight, evidence, and scope easier to understand

Practical FAQ

Questions cautious teams often ask first

These questions matter because careful adoption in life sciences depends on scope, review discipline, and clarity about what the system is and is not intended to do.

Who is this for?

Corentis is designed for operational, quality, governance, and document-heavy review teams working around regulated life sciences processes where oversight and evidence matter.

Is this a diagnostic or treatment product?

No. Corentis is positioned as a governance and oversight layer for bounded operational AI workflows. It is not presented as a diagnostic, treatment, or clinical decision system.

What kind of workflows are in scope?

The focus is on bounded operational workflows such as document review, protocol-deviation triage, or summarisation support where human sign-off and process visibility remain essential.

What does Corentis add?

The platform is designed to add testing, control mapping, review gates, runtime visibility, and evidence generation around a workflow rather than replace the underlying tools already in use.

Why does evidence matter here?

In regulated environments, confidence depends on more than output quality. Teams need to know what was checked, who reviewed it, what exceptions arose, and what record remains afterwards.