Nonclinical Strategy & IND/CTA Readiness
Target validation & translational rationale · nonclinical package · starting dose · IND/CTA gap analysis · CMC coordination · pre-submission health authority meetings.
Preclinical to Clinical
From Molecule to Trial
End-to-end support for emerging biotech navigating the preclinical-to-clinical transition.
The transition from a nonclinical data package to a running Phase I study is a consequential step in drug development. Emerging biotech teams reach it with strong science and limited clinical infrastructure, and it is precisely here that IND strategies can be sharpened, dose-escalation schemas refined, and regulatory timelines protected.
One relationship
No gaps between preclinical and clinical
Inventio Science works with a team of senior experts and specialist partners with 20+ years of experience, across nonclinical strategy, medical affairs, translational science, and competitive intelligence, to provide a fully coordinated pathway from molecule to clinical proof-of-concept. One relationship. No gaps between preclinical and clinical. Smooth oversight from strategy to execution.
Working as one
Expert partner and Inventio Science, working as one
Expert partner
Programme-focused nonclinical strategy, translational science, medical affairs, competitive intelligence, and product development.
Inventio Science In-House
Senior-led clinical execution across IND/CTA, Phase I–II trial operations, regulatory affairs, pharmacovigilance, biostatistics, data management.
How we cover the full development arc
Stage
Expert Partner
Inventio Science (In-House)
Nonclinical & translational strategy
Target validation · nonclinical development strategy · PK/PD modelling · due diligence · scientific narrative for IND/CTA
Nonclinical package review · starting dose justification · IND/CTA gap analysis · regulatory meeting preparation
Medical affairs & competitive intelligence
Therapeutic area positioning · KOL engagement · competitive landscape · standard-of-care analysis
Clinical development strategy · protocol design · go/no-go decision frameworks · Phase I–II programme planning
Phase I clinical execution
Scientific and medical advisory input
Full Phase I operations: site setup, CRA monitoring, SAE/SUSAR reporting, TMF management, biostatistics and data management
Global reach
Market access intelligence · regional medical affairs input
IND/CTA filings · global site selection · sponsor oversight frameworks
One coordinated pathway, from nonclinical package to clinical proof-of-concept, without the overhead of building a full internal development function.
The journey
The development stages we navigate together
Phase I: FIH & Dose Escalation
FIH protocol & escalation schema · DSMB · site setup & CRA monitoring · SAE/SUSAR · PK/PD-informed dose decisions · go/no-go decision.
Phase I → II Transition & Proof-of-Concept
End-of-Phase I regulatory strategy · FDA/EMA briefing · Phase II proof-of-concept design · biomarker-guided patient selection · trial design & statistical framework.
Global Scale-Up
IND/CTA filings (FDA · EMA · MHRA · ANVISA · TGA) · site selection · FSP resourcing scaled to phase & budget · sponsor oversight frameworks · Phase I–II budget architecture.
Global reach. Built for lean teams.
Emerging biotechs can outsource global teams that operate across regulatory jurisdictions and access Phase I units worldwide:
- Regulatory filings: one unified scientific narrative with jurisdiction-specific formatting.
- Scaled resourcing: functional expertise adapted to each study phase, from full CRO infrastructure to a targeted, fractional development team.
- Oversight without headcount: governance frameworks and milestone reporting that give lean sponsor teams full programme visibility.
- Budget architecture aligned to fundraising: financial planning from IND through Phase II database lock, structured around go/no-go milestones.
The goal is not just to run your Phase I study.
It is to position your molecule and your company for the Phase II investment decision with the strongest possible scientific, regulatory, and operational foundation.
Who is this for?
Built for the teams making the leap into the clinic
Emerging biotech advancing a molecule toward Phase I with limited internal clinical infrastructure.
Academic spin-offs with strong nonclinical data but no medical affairs or regulatory development team.
Virtual and lean biotech teams seeking a full development function without building one in-house.
Series A/B companies under investor pressure to reach Phase II proof-of-concept efficiently.
Programmes entering clinical development.
From your molecule to your first patient
Tell us where you are in the preclinical-to-clinical transition and we will map the pathway with you.