AIMS Service Category

Global Inbound / Outbound Development Strategy

Plan data use, clinical/regulatory pathways, and execution sequence for the target country or market.

AIMS proposes executable development paths for inbound Korea development and outbound global development by reviewing existing data usability, additional evidence needs, target countries, regulatory expectations, cost, and timeline.

GRS E5 Assessment Bridging Strategy Dossier Gap Analysis PPS Plan
Why it matters

The same data may be viewed differently across countries.
If the target country strategy is poorly designed, existing data may be underused and unnecessary trials may be added. Ethnic factors, local practice, regulatory expectations, and patient preference should be considered early.

Recommended for clients using foreign data for Korean development
or taking Korean assets overseas.

This category supports clients that need to determine how much existing data can be used, where additional trials should be placed, whether bridging or patient preference evidence is needed, and how to sequence execution for the target market.

AS IS
  • Foreign data are assumed to be directly usable in Korea.
  • It is unclear how Korean data will be accepted in the target global market.
  • All trials are assumed to be needed in the target market.
  • Ethnic factors and bridging needs are reviewed too late.
  • Patient preference and benefit-risk acceptability are not reflected in the development strategy.
TO BE
  • The usability of foreign data and additional evidence needs are defined early.
  • The evidence package and trial placement strategy for the target market are established.
  • Target-market trials, third-country execution, and MRCT options are compared.
  • ICH E5-based extrapolation and bridging needs are assessed in advance.
  • Patient preference and benefit-risk acceptability are reflected in development and regulatory strategy.

How global development routes are configured

Inbound and outbound development are not simple submission routes. AIMS aligns existing data, local expectations, clinical feasibility, bridging logic, and target-market value into an executable strategy.

Inbound strategy

Determine how foreign data can support Korean development and what additional evidence is needed.

01

Outbound strategy

Plan which trials should be run in which countries and in what sequence.

02

E5 bridging

Assess ethnic factors and extrapolation of existing clinical data.

03

Patient preference

Generate patient-centered evidence to support benefit-risk and positioning.

04

Service modules

Foreign data use, global trial placement, ICH E5 bridging, and patient preference studies are
combined according to target market needs.

Inbound Korea Development Strategy

This service defines the Korean clinical/regulatory path for assets developed overseas, including data usability, additional evidence needs, cost, and timeline.

Core question
What clinical and regulatory path should a foreign-developed asset follow in Korea?
Why this service matters
If foreign data usability is unclear, sponsor responses to Korean regulatory questions or supplementation requests may be delayed.

What can go wrong
if this is not addressed?

01

Foreign data usability is unclear

Korean regulatory questions or data requests may be delayed.

02

Local practice differences are overlooked

Population and trial design may not fit the Korean clinical context.

03

Korean feasibility is not checked

CRO/site selection, recruitment, and timeline planning may be delayed.

Multidisciplinary participation

The radial chart shows participating expertise only. RACI roles and contributions are shown in the table.

Inbound Korea Strategy multidisciplinary participation graph
Accountable Responsible Consulted Informed

Role by expertise

RoleExpertiseContribution
ARegulatory Strategy

Owns Korean development path, meeting strategy, and dossier direction.

RClinical Development

Defines clinical need, target population, endpoints, and Korean trial needs.

RClinical Operations

Assesses Korean CRO/site/vendor feasibility, cost, timeline, and operational risks.

CClinical Pharmacology

Advises PK/PD, DDI, bridging, and dose applicability.

CRWD/RWE Strategy

Supports Korean patient characteristics, treatment patterns, and recruitment feasibility.

CCMC / Quality

Assesses Korean usability and gaps in quality data.

When clients need this service

Client situationAIMS value
A foreign-developed asset is being introduced into Korea.Defines Korean regulatory and clinical development path.
Foreign clinical data need to be reused.Assesses what can be used and what additional evidence is needed.
Korean trial feasibility is uncertain.Reviews CRO/site, recruitment, cost, and timeline options.

Workflow

01

Review foreign data

Assess nonclinical, clinical, CMC, and clinical pharmacology data.

02

Assess Korean usability

Identify what can be explained with existing data.

03

Define Korean gaps

Identify additional clinical, regulatory, or quality data needs.

04

Plan Korean execution

Define CRO/site/timeline/cost and regulatory meeting strategy.

Representative deliverables

Korea development entry strategy report

Clinical and regulatory route for Korean entry.

Korean dossier gap analysis

Usability of foreign data and additional evidence needs.

Korean clinical trial necessity assessment

Need, purpose, population, and key endpoints of Korean trial.

Regulatory meeting strategy

Meeting purpose, key issues, questions, and expected responses.

Relevant standards by service

AIMS defines the standards and guideline anchors that should be considered for each service, rather than treating them as optional references.

ServiceRelevant standardsHow they are applied
Inbound Korea Development StrategyICH E5(R1), E17, E6(R3), E8(R1), E3, M12Assess foreign clinical data usability, ethnic factors, MRCT data, clinical quality, and DDI/PK differences.
Outbound Global Development StrategyICH E17, E5(R1), E6(R3), E8(R1), E3, M12, M15Plan MRCT, target-market acceptability, foreign clinical data use, GCP quality, and model-informed extrapolation.
ICH E5 Bridging StrategyICH E5(R1), E17, M12, M15Evaluate intrinsic/extrinsic ethnic factors, bridging needs, DDI/PK, and model-based support.
Patient Preference StudyICH E22, E8(R1), E6(R3), E9(R1)Design, conduct, analyze, and apply patient preference evidence in benefit-risk and development strategy.

Core terms

GRS

Global regulatory strategy for target markets and agencies.

Bridging strategy

A plan to justify whether existing data can be extrapolated to another region.

MRCT

Multi-regional clinical trial designed to support evidence across regions.

PPS

Patient preference study used to understand treatment attribute preferences and benefit-risk acceptability.