Why PreQlinic?
We’ve seen the problems first‑hand and validated them across the industry.
Biotech founders tell us PreQlinic would have helped to “cut through the chaos”, dramatically reduce planning time and enable clearer, more defensible decisions.
Investors are genuinely excited by the prospect of gaining early insight into programmes and understand what they are backing.
Industry specialists – from regulators to CRO leaders – see how poor planning, weak programme management and inconsistent documentation slow teams down and inflates costs.
PreQlinic delivers what they are all asking for: clarity, structure, efficiency and traceability through the preclinical phase.
RECOGNISING THE PAIN POINTS
What we experienced is felt across the industry
Limited cash runways, fragmented delivery models and late-emerging risks are placing increasing pressure on preclinical programmes. The evidence points to the same underlying need: better-connected decisions before time and capital is committed.
phase-Appropriate Development
FDA (Sep 2026)
The FDA notes that some companies generate and submit more data than is needed for Phase 1 – creating unnecessary work and delaying clinical entry.
”By focusing exclusively on phase-appropriate requirements, companies can save 6 to 12 months of development time.”
Regulatory Readiness
MHRA (Apr 2026)
Most applications are eventually approved, but many do not arrive ready for approval. The MHRA says common and avoidable information gaps can add up to 21 days to a Phase 1 authorisation.
”More than half of all applications require additional information to be submitted before they are considered approvable.”
Financing Pressure
EY Beyond Borders (Jun 2026)
Capital remains available, but it is increasingly selective. For companies operating with a short runway, every unnecessary study, delay or unresolved risk reduces their room to manoeuvre.
”A third of companies [have] less than one year’s worth of cash on hand.”
Process Improvement
McKinsey (Jan 2026)
Better sequencing, governance and execution can materially shorten the route from candidate nomination to first-in-human studies.
”Pharmaceutical companies can often cut time to reach FIH trials by 40 percent or more through process improvements.”
The journey...
PreQlinic didn’t begin with a platform. It began with a question - why, when so many talented people are involved, do promising preclinical programmes still encounter problems that could have been seen earlier?
Over the years, we worked alongside early-stage biotechs, CROs, academic laboratories, consultants and regulators. The science changed from programme to programme, but the challenges around it were often surprisingly similar.
Important knowledge was spread across documents, suppliers and individual experience. Assumptions were understood by some people but invisible to others. Scientific, regulatory and investment decisions were being made, but not always together.
Each decision might make sense on its own. The difficulty came later, when the connections between them began to matter. A change in one workstream would affect another. A dependency would emerge at the wrong moment. A question that could have been explored early would surface only after significant time and capital had been committed.
We saw teams working hard to respond - not because they lacked expertise, but because they lacked a shared view of the programme. That stayed with us.
We began to imagine a different approach - one where the logic behind a programme is made visible from the outset. Assumptions can be challenged early, dependencies understood clearly, and risks examined before they become costly problems. All of this delivered in a way that is efficient, structured, and time‑effective.
That idea became PreQlinic.
NAVIGATING THE MAZE
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.