PreQlinic®
PLANNED DE-RISKING
For lean biotechs and their investors.
A preclinical plan is usually assembled over months, by separate experts and consultants, at a cost in the hundreds of thousands. With PreQlinic, a fully integrated plan is ready in days, at a fraction of the cost.
For a candidate ready for preclinical development, we design the CTA or IND programme across modalities, around a defined scientific and regulatory pathway. Milestones support the investment case and set a clear route to first-in-human trials.
NAVIGATING THE MAZE
A clear way forward.
Activities, assumptions, dependencies and decision points are made visible before execution, so teams and investors can see what should be learned first, what can wait, and why.
In the usual consulting model, problems surface after advice has been commissioned as laboratory work. Planned de-risking places those problems on the table before the work starts.
WHAT PLANNED DE-RISKING MEANS
One integrated programme. One investable story.
Integrate investors, regulation and science
Scientific, regulatory and investment decisions cannot be made in isolation. Planned de-risking connects them within one programme, aligning the evidence required, the risks being addressed and the milestones that support the investment case.
Waste reduction
When dependencies and decision points are unclear, studies are duplicated, programmes are repeatedly redesigned and capital is committed too early. Planned de-risking focuses resources on the work that matters, in the right sequence and for a defined purpose.
Efficient programmes
Risks identified late create delays, increase costs and weaken confidence in the path forward. Planned de-risking makes assumptions explicit, surfaces critical risks early and creates a coordinated route through preclinical development.
THE PREQLINIC APPROACH
Platform, process & people.
PLATFORM
CONNECTS THE PROGRAMME
Our proprietary knowledge graph acts as the connective tissue for the entire programme – linking product context, scientific evidence, regulatory requirements, activities, dependencies, assumptions and decisions.
Rules-based and AI-enabled infrastructure uses those relationships to construct, test and maintain one coherent, traceable programme for decision-making and downstream review.
PROCESS
STRUCTURES THE ROUTE
A disciplined planned de-risking process brings science, regulation and investment into one decision framework. It identifies and ranks the uncertainties that govern progress, sequences critical learning through defined gates and aligns each commitment of capital with the evidence needed to support it.
The result is a focused, credible preclinical programme built around decisions.
PEOPLE
APPLY SPECIALIST JUDGEMENT
Specialist scientific judgement remains central wherever evidence is incomplete, uncertainty is material or trade-offs cannot be automated. Independent experts challenge assumptions, interpret conflicting evidence and resolve decisions across pharmacology, toxicology, bioanalysis, CMC and regulation.
Human authority is retained at every critical gate, with recommendations, rationale and accountability captured throughout.
The platform connects. The process structures. Only people decide.
OUR SERVICES
A focused route through the preclinical process.
Our services operate within one connected approach. The scope is shaped around the work required to create and support a credible route forward.
1. Programme design & planning
A structured preclinical programme connecting relevant activities, sequencing, dependencies, decision points and indicative resource requirements.
2. Programme coordination
Support across internal teams, specialists, laboratories and CROs so that changes in one workstream are understood across the programme.
3. Documentation & assurance
A clear connection between programme rationale, completed activities and documentation prepared for regulatory and investor scrutiny.
4. Investor programme visibility
A coherent view of milestones, assumptions, dependencies and the relationship between capital, learning and risk reduction.
FREQUENTLY ASKED QUESTIONS
Clear answers before the first conversation.
When should a biotech engage PreQlinic?
PreQlinic is designed for a candidate entering preclinical development, when the team needs to define or strengthen the route towards first-in-human trials.
Does PreQlinic assess whether the candidate is viable?
No. We begin on the assumption that the sponsor has selected a viable candidate. Our role is to build a bespoke development programme around it.
Will PreQlinic review all our existing documentation and results?
Not routinely. We identify preliminary work that materially affects assumptions, constraints or planned activities. The aim is a focused review of what matters, not a lengthy re-examination of the discovery record.
Is the programme a standard checklist?
No. The programme is built around the candidate, modality, indication, route of administration, regulatory destination and available capital.
What does AI do?
AI supports bounded activities such as structuring inputs, mapping relevant activities, connecting dependencies and assisting with drafts. It does not make autonomous scientific or regulatory decisions, that is the responsibility of the deterministic
Does PreQlinic guarantee CTA or IND clearance?
No. Regulatory outcomes depend on the candidate, generated data, execution quality, sponsor decisions and the relevant authority.
CHARTING A PATH TOGETHER
Let's make the route forward clearer
Whether you’re shaping a new preclinical programme or taking another look at an existing one, we can help you bring the critical decisions, dependencies and risks into view – before more capital is committed.