Turning Development Evidence into IND-to-FIH Decisions

Onea Clinical helps emerging biotech teams integrate nonclinical, CMC, PK, clinical, and regulatory evidence, identify critical development gaps, inform FIH strategy and clinical study design, and support IND preparation.

LATEST UPDATE｜2026.10　

Two articles by Onea Clinical Founder Jason Lu, PhD, accepted for publication by Applied Clinical Trials

1. AI in Clinical Study Design: What Sponsors Need to Know About LLMs, Data, and Decision Support

2. AI Can Draft the CSR Faster. But Does That Make Drug Development Faster?

Core Capability

From Development Evidence to Decision-Ready Clinical Study Design

Onea Clinical helps Sponsors translate development evidence from CMC, nonclinical, PK, existing clinical data, scientific literature, and regulatory sources into Clinical Study Designs that can support informed discussion and decision-making.

Our focus is not simply on drafting a Protocol. Before a Protocol is finalized, we examine whether key design questions across population, dose / regimen, endpoints, statistics, safety, and operational feasibility are adequately supported, which assumptions remain unresolved, and what trade-offs exist among different design options.

We do not start with a blank Protocol. We start with the question: “What does the next study need to answer?”

A Clinical Study Design Must Address Multiple Interconnected Questions

Onea brings development evidence, scientific assumptions, and operational constraints into a common design framework to compare design options, identify critical assumptions, and clarify where additional evidence or expert input may still be required.

01｜Study Population

Target population · Inclusion / exclusion criteria · Stratification / enrichment assumptions

02｜Dose & Regimen

Dose selection · Dosing regimen · Escalation / optimization considerations

03｜Endpoints

Roles and evidence basis for primary, secondary, and exploratory endpoints

04｜Statistical Assumptions

Effect assumptions · Sample size drivers · Comparison framework and key statistical assumptions

05｜Safety & Monitoring

Known and potential risks · Monitoring needs · Stopping / escalation considerations

06｜Operational Feasibility

Enrollment · Site burden · Study procedures · Supply and other operational constraints

From Fragmented Development Evidence to a Sponsor Decision-Ready Study Design

Development Question

Clarify the critical question the next study needs to answer.

Evidence & Constraints

Integrate clinical, nonclinical, PK, existing product evidence, scientific literature, regulatory requirements, and operational constraints.

Design Options & Trade-offs

Compare design options and assess their respective advantages, risks, and trade-offs.

Unresolved Questions

Identify areas where evidence remains insufficient and where additional expert judgment is required.

Decision-Ready Study Design

Integrate available evidence, design options, key assumptions, trade-offs, and unresolved questions into a Study Design that provides the foundation for subsequent Protocol development.

Onea does not generate a single “standard answer” for the Sponsor. We organize the available evidence, design options, key assumptions, trade-offs, and unresolved questions into a Study Design that supports professional discussion and decision-making—and provides a structured foundation for subsequent Protocol development.

Identify Potential Amendment Drivers Earlier

From population, dose / regimen, endpoints, statistics, and safety to operational feasibility, Onea helps teams identify unresolved design questions and cross-functional conflicts before Protocol Freeze.

The goal is not simply to produce a Protocol faster, but to identify potential amendment drivers earlier.

Onea Clinical Services | Professional Services

From Development Readiness to FIH, Support Tailored to the Sponsor’s Development Stage

Onea Clinical provides Sponsor-side IND-to-FIH Development Support for emerging biotech teams, integrating development evidence, identifying critical gaps, and providing stage-appropriate support across development readiness, FIH strategy, clinical study design, IND preparation, and clinical / regulatory writing.

Services may be engaged independently or combined across a clinical development program.

FIH Strategy & Clinical Study Design

Integrate development evidence and critical assumptions to support starting-dose framing, population, dose / regimen, endpoints, statistics, safety, and operational feasibility considerations for FIH Study Design.。

01 | Development Readiness & Gap Analysis

Integrate available development evidence to identify evidence gaps, dependencies, unresolved issues, and critical questions that may need to be addressed before the next development milestone.

02 | Pre-IND & FIH Development Strategy

Structure key development questions, Pre-IND written materials, starting-dose framing, and the cross-functional evidence and assumptions required to support FIH Study Design.

03 | IND Package Development & Integration

Integrate CMC, nonclinical, clinical, and other cross-functional sources to support IND-ready document development, clinical writing, and cross-functional package review.

04 | Clinical Development Due Diligence

Provide structured Clinical Development DD across readiness, evidence, dependencies, milestone relevance, and development risk.

Clinical & Regulatory Document Development

Protocol / Protocol Synopsis · IB · ICF · CSR · Pre-IND Written Materials · Other Agreed Clinical-Development Documents

Documents are the expression layer of development decisions—not a substitute for unresolved development judgment.

Two Engagement Pathways: Sponsor / CRO

Biotech / Sponsor

Extend internal clinical development capabilities and access flexible professional support without building a full-scale internal team.

Onea Clinical can support:

AI-Assisted Clinical Study Design
IND Readiness / Pre-IND Support
IND / Clinical Document Development
Clinical Development DD

CRO／Development Partner

Provide modular professional support when internal capacity is constrained or specialized development expertise is needed.

Onea Clinical can support:

Study Design Support
Clinical Writing / Document Review
Source & Document Readiness
QC / Overflow Support

Onea AI Technology Platform

AI Expands Analytical Capacity. Humans Retain Critical Judgment.

Clinical development is complex not simply because of the volume of information, but because critical evidence, data discrepancies, assumptions, and dependencies are often distributed across different study reports, documents, and regulatory sources.

The Onea AI Technology Platform applies AI to evidence extraction, cross-document comparison, evidence organization, issue identification, and scenario analysis. It helps professionals systematically identify development questions, while final scientific, clinical, statistical, and regulatory judgments remain human-led.

AI-Amplified. Human-Led. Evidence-Grounded.

Built on a governed multi-model workflow, with a validation framework designed in alignment with core GxP principles.

Turning Complex Evidence into Better-Supported Study Design

The Onea AI Technology Platform helps integrate critical information across study data, clinical evidence, scientific literature, and regulatory sources to systematically identify cross-document discrepancies, evidence gaps, unresolved questions, and key dependencies.

AI expands analytical capacity and helps teams examine Study Design more comprehensively. Critical scientific, clinical, statistical, and regulatory judgments remain the responsibility of qualified professionals.

Evidence Intelligence

Identifies development-relevant evidence, discrepancies, and gaps across multiple sources.

Development Intelligence

Organizes readiness, unresolved questions, and key dependencies to clarify issues that may affect the next development step.

Study Design Intelligence

Integrates evidence, assumptions, and operational feasibility to compare design scenarios and support Study Design development and review.

Document Intelligence

Translates confirmed development decisions and design choices into consistent, traceable clinical and regulatory documents.

AI Expands Analysis. Critical Decisions Remain Human-Led.

Regulatory Orientation

Applicable regulations, ICH guidelines, and regulatory-agency public guidance provide important inputs into development analysis and must be assessed for applicability to the specific development stage.

Source TraceabilityCritical data, assumptions, and conclusions retain clear links to their underlying sources.

Human Decision AccountabilityAI supports organization, comparison, and identification of candidate issues; professional judgment and final decisions remain the responsibility of humans.

Uncertainty ManagementKnown assumptions, dependencies, unresolved questions, and residual uncertainty are explicitly identified rather than presenting uncertain issues as definitive conclusions.

AI Is Moving Upstream—from Document Production to Study Design and Development Decision Support.

The role of AI in clinical development is gradually extending beyond medical writing, data processing, and workflow automation toward upstream evidence synthesis, study design, protocol optimization, and development decision support.

001 | Evidence Integration

Integrates scientific, clinical, and development evidence to help teams identify information gaps and critical development questions.

02｜AI-Assisted Study Design

Supports analysis and comparison of study-design questions across population, dose and regimen, endpoints, statistics, safety, and operational feasibility.

03｜Protocol Optimization

Extends beyond Protocol drafting to the prospective identification of protocol complexity, feasibility issues, and potential execution risks.

04｜Human-Governed Decision Support

AI expands analytical capacity, while critical scientific, clinical, statistical, and regulatory judgments—and final development decisions—remain with qualified professionals and the Sponsor.

Onea Clinical’s direction is to bring AI earlier into the clinical development process—not to replace professional judgment, but to support more complete, traceable, and systematically reviewed Study Design and development decisions.

Sponsor-side Clinical Development Partner

Onea Clinical Services supports emerging biotech teams before IND development, clinical document preparation, and CRO handoff through evidence organization, cross-document consistency review, gap assessment, and package readiness support. AI is used only as a controlled internal workflow to improve organization, comparison, and drafting efficiency; all professional judgments, risk assessments, and deliverables remain subject to human review and decision-making.

From Development Evidence to FIH, It Takes More Than an IND Package.

Before entering First-in-Human development, Sponsors must integrate nonclinical, CMC, PK, clinical, and regulatory evidence while progressively addressing development gaps, starting dose, study design, IND readiness, and downstream execution requirements.

Onea Clinical starts with the Sponsor’s development questions. We help teams organize evidence across development stages, identify unresolved issues, and translate fragmented cross-functional information into a decision-ready foundation for the next development milestone.

Where Onea Can Support

Onea Can Engage at Different Stages of the Sponsor’s Development Pathway

Early Development

Readiness & Gap Analysis、Evidence Integration

Pre-IND / FIH Planning

Development Questions、FIH Strategy、Study Design

IND Preparation

IND Package Development、Clinical / Regulatory Writing、Cross-functional Integration

Approaching FIH

Readiness Review、Open Issues、Sponsor Decision Support

Onea focuses on Sponsor-side development support. We do not replace CMC, toxicology, clinical pharmacology, biostatistics, or other specialized expertise, nor do we provide full-service clinical trial execution.

Three Core Values of Onea Clinical

Decisions Before Documents

We help teams address critical development questions earlier, rather than waiting until they surface during Protocol development or trial execution.

The goal is not simply to produce documents faster, but to identify critical issues earlier and reduce avoidable downstream rework across the development timeline.

AI Expands Analysis. Humans Retain Judgment.

AI expands analytical capacity and supports evidence organization and comparison, while final development decisions remain with the Sponsor and appropriate subject-matter experts.

When specialized input is required, Onea works with the Sponsor, CRO, or relevant experts. Final development decisions remain with authorized human decision-makers.

Lean, Flexible Collaboration

Designed for resource-constrained teams that need focused professional support without building a large fixed organization.

Onea provides targeted support based on actual development needs, allowing teams to access the right expertise without unnecessary organizational overhead.

Make Development Decisions More Testable Before the Next Clinical Milestone

Whether you are preparing an IND, planning the next clinical study, preparing for a Pre-IND interaction, or need senior clinical writing and review support, Onea Clinical can begin by assessing your current development stage and the critical issues that remain unresolved.

Onea Clinical is the clinical development professional services business of Onea Biotech Co., Ltd.

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Jason Lu

Founder, Onea Clinical

jason.lu@oneabiotech.com

AI-Assisted Production · Clinical PM Integration · Human Professional Review

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From Development Evidence to FIH, It Takes More Than an IND Package.

Three Core Values of Onea Clinical

Make Development Decisions More Testable Before the Next Clinical Milestone

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