Onea Clinical Services | Professional Services

From Development Readiness to FIH, Supporting the Sponsor’s Critical Development Work

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

AI-Assisted. Human-Led. Evidence-Grounded.

Select the Support You Need Based on Your Development Stage

Onea does not require clients to start from the first stage or bundle services into a fixed package. Teams can engage Onea based on their current development stage, existing internal capabilities, and CRO / external expert resources.

01 | Development Readiness & Gap Analysis

Organize existing development evidence and identify:
Evidence gaps · Dependencies · Unresolved issues · Development questions

Best suited for: Sponsors determining the next development milestone, preparing for Pre-IND, or reassessing an existing development package.

02 | Pre-IND & FIH Development Strategy

Includes:
Key development questions · Pre-IND written support · Starting-dose framing · FIH strategy · Clinical study design

03 | IND Package Development & Integration

Includes:
IND package development · Source integration · Cross-functional document integration · Readiness review

04 | Clinical Development Assessment & DD

Includes:
Evidence mapping · Readiness issues · Key dependencies · Milestone relevance · Management questions

Onea provides IND development, document integration, and readiness support. We do not provide eCTD publishing, formal regulatory submission services, or regulatory representation on behalf of the Sponsor before regulatory authorities.

01 | AI-Assisted Clinical Study Design

The Protocol Should Not Be Where Study Design Is Discovered.

When Is This Most Relevant?

When a Sponsor is preparing for FIH, Phase 1, PoC, or subsequent clinical development, but key elements such as population, dose / regimen, endpoints, sample size assumptions, or operational feasibility have not yet been fully integrated, Onea helps complete the study-design reasoning before formal Protocol development begins.

How Onea Supports the Process

Define the development question
Population and key eligibility considerations
Dose / regimen and available evidence integration
Endpoints and assessment strategy
Comparator / control considerations
Statistical assumptions and scenario analysis
Operational feasibility
Regulatory considerations
Key assumptions, dependencies, and unresolved questions

Deliverables

Protocol Synopsis
Study Design Rationale
Scenario / Assumption Summary

02 | Pre-IND Meeting Support

Not every question needs to go to the Agency. Focus first on the questions that truly require regulatory clarification before committing to downstream execution.

When is this useful?

When a Sponsor is approaching an IND or first-in-human study, but selected nonclinical, clinical pharmacology, study design, or development assumptions still require regulatory feedback, Onea helps translate these issues into clear, evidence-based regulatory questions that the Agency can meaningfully address.

How Onea can help

Pre-IND readiness review
Identify and prioritize key regulatory questions
Develop Sponsor positions and supporting rationale
Evaluate alternative scenarios and options
Integrate Briefing Package content
Check consistency across meeting questions and supporting materials
Reassess development implications following Agency feedback

Deliverables

Pre-IND Question Package
Briefing Package Support
Agency Feedback Impact Assessment

Onea 提供 IND development、document integration 與 readiness support；不提供 eCTD publishing、正式 regulatory submission 或代表 Sponsor 與主管機關進行 regulatory representation。

03 | IND Package Integration

An IND is not a collection of documents—it is a connected chain of evidence.

When is this useful?

When a Sponsor has the core CMC, nonclinical, and clinical planning materials in place but needs to integrate inputs from multiple functional teams into a consistent and traceable IND package, Onea provides Sponsor-side integration and writing support.

How Onea can help

Review source package readiness
Assess consistency across key CMC, nonclinical, and clinical data
Connect the rationale across starting dose, exposure, safety strategy, and protocol design
Support CTD / IND clinical and nonclinical summaries
Perform cross-document consistency review
Strengthen source traceability and quality control

Deliverables
Depending on the agreed SOW, deliverables may include:

IND Readiness / Integration Report
CTD Module 2 Supporting Documents
Clinical / Nonclinical Summary Support
Cross-Document Consistency Review

IND Readiness & Gap Analysis

Not Just What Is Missing—Which Gaps Actually Affect the Next Development Decision?

When is this useful?

When a team has accumulated CMC, nonclinical, PK, or other development evidence but remains uncertain whether the existing evidence is sufficient to support Pre-IND, IND, FIH, or the next clinical development milestone, Onea helps organize the available evidence, identify unresolved critical questions, and assess whether those gaps materially affect the next development decision.

How Onea can help

Review available development data and critical evidence
Assess cross-document data and narrative consistency
Identify evidence gaps and critical dependencies
Assess potential impact on target development milestones
Prioritize remediation needs and recommend next steps

Deliverables

Readiness and Gap Assessment Report
Evidence / Dependency Summary
Recommended Next-Step Actions

Conventional Gap Analysis first asks, “What is still missing?” Onea goes one step further: “Does this gap materially change the development decision, and what level of resolution is actually required?”

From Gap Identification to Sponsor Decision

Evidence gap ≠ Study gap.
Missing evidence does not automatically mean that a new study is required. The first question is whether the existing evidence is sufficient to support the critical development decision.

Clinical risk controls can manage residual uncertainty, but they cannot replace evidence required to support the Study Design itself.

Deliverables:

IND Readiness & Decision-Critical Gap Assessment
Key evidence gaps and decision impact
Resolution priorities and unresolved questions
Sponsor decision points and necessary next-step recommendations

Clinical & Regulatory Writing

Documents express development decisions—they do not replace them.

When is this useful?

Onea works from approved and usable source materials to support structured drafting, source traceability, cross-document consistency review, and controlled quality review. If a material development decision remains unresolved during drafting, the relevant content is clearly flagged for confirmation rather than presented as a settled conclusion.

Clinical Development Due Diligence

Validate what the evidence supports—without making the transaction decision.

When is this useful?

In-Licensing

Out-Licensing / Partnering

Pre-Investment Clinical Development Assessment

Asset / Program Review

How Onea can help

Compare Sponsor claims against source evidence
Assess clinical and development evidence
Identify evidence gaps and inconsistencies
Examine key development assumptions
Map critical development dependencies
Identify residual uncertainties
Assess potential implications for subsequent clinical development

Clear Boundaries

Onea provides independent clinical development evidence assessment. We do not provide company valuation, transaction scoring, or investment recommendations.

Not Sure Where to Start?

Sponsor challenges do not always fit neatly into a single service category. If your clearest question is “Which development milestone is currently blocked?” rather than “Which service should we purchase?”, start with a focused preliminary discussion.

Onea will review the current development stage, available evidence, target milestone, and major unresolved questions to help define an appropriate project scope.

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

Site Navigation

Jason Lu

Founder, Onea Clinical

jason.lu@oneabiotech.com

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

──────────────────────────────────────────────

｜Privacy Policy

From Development Readiness to FIH, Supporting the Sponsor’s Critical Development Work

© 2026 Onea Biotech Co., Ltd. All rights reserved.