AIMS Service Category

Core Evidence Generation Roadmap

Design which evidence should be generated first and when development
decisions should be made.

AIMS defines how nonclinical, CMC, clinical pharmacology, and clinical evidence will be used in development decisions,
then aligns evidence sequence and decision criteria to enable Quick-win / Fast-fail.

CDP Evidence Roadmap Decision Matrix Go/No-go Criteria Evidence Package
Why it matters

The number of studies matters less than having the right evidence at the right time.
When evidence generation is not sequenced, IND readiness, FIH entry, PoC, and partnering discussions become disconnected, increasing cost and time.

Recommended for companies preparing IND or
early clinical entry without a clear evidence sequence.

This category supports clients whose development rationale and first target are partly defined, but who need a practical roadmap for nonclinical and clinical evidence generation, dependencies, and decision criteria.

AS IS
  • A list of IND-enabling studies exists, but evidence to prove pipeline value is insufficient.
  • Nonclinical, CMC, clinical pharmacology, and clinical activities are planned separately.
  • Dependencies and parallel execution opportunities are unclear.
  • Data to be obtained after FIH are not clearly defined.
  • Criteria for continue, modify, or stop decisions are not pre-specified.
TO BE
  • The core value to be proven and required evidence are defined.
  • Pre- and post-IND evidence generation paths are connected in one roadmap.
  • Precedence and parallelizable tasks are separated to optimize cost and timing.
  • Evidence needs for FIH, PoC, clinical pharmacology, and expansion studies are aligned.
  • Generated evidence can support timely continue, modify, or stop decisions.

The roadmap connects development logic with execution.

A core evidence roadmap is not a long study list. It defines the value the pipeline must prove, the evidence required, and the decision threshold for moving to the next step.

Core value to prove

Define the performance and differentiation claims that support the development rationale.

01

Required evidence

Clarify how nonclinical, CMC, clinical pharmacology, and clinical evidence fit together.

02

Decision criteria

Define when to continue, modify, stop, expand, or partner based on generated evidence.

03

Service modules

Nonclinical and clinical evidence generation and decision criteria are combined into an executable roadmap.

Nonclinical Development Roadmap

This service defines which nonclinical evidence should be generated before and after IND, how studies depend on each other, and how evidence supports pipeline value and clinical entry.

Core question
Which nonclinical evidence should be generated, in what order, and by what approach?
Why this service matters
Nonclinical development is not only an IND-enabling package. It must also establish translational logic, dose rationale, safety margin, and partner-facing confidence.

What can go wrong
if this is not addressed?

01

IND-only planning

Differentiation or partner-facing
evidence may be insufficient.

02

Dose and exposure mismatch

Efficacy and toxicity studies may not support FIH dose or safety margin interpretation.

03

CMC misalignment

Study material changes or batch
readiness issues may trigger delays or repeat studies.

Multidisciplinary participation

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

Multidisciplinary participation graph
Accountable Responsible Consulted Informed

Role by expertise

RoleExpertiseContribution
ANonclinical Development

Owns nonclinical evidence strategy and study sequencing.

RClinical Pharmacology / MIDD

Connects PK/PD, NOAEL/MABEL, exposure, and FIH dose rationale.

CCMC / Formulation

Advises material, formulation, batch, and analytical readiness.

CRegulatory Strategy

Aligns evidence package with IND and post-IND expectations.

CClinical Development

Connects nonclinical evidence to entry indication and early clinical strategy.

CBusiness Development

Advises partner due diligence expectations.

When clients need this service

Client situationAIMS value
Nonclinical studies are planned as a list but not as decision evidence.Builds a study sequence linked to development decisions.
FIH dose rationale or safety margin is weak.Aligns efficacy, toxicity, PK/TK, and exposure rationale.
CMC and nonclinical timelines are not aligned.Clarifies material requirements and study timing dependencies.

Workflow

01

Review current data

Assess efficacy, PK/TK,
safety, CMC, and indication
rationale.

02

Define evidence gaps

Identify IND-enabling and
value-supporting evidence
needs.

03

Sequence studies

Define dependencies,
parallel paths, and decision
points.

04

Connect to clinical entry

Link nonclinical results to FIH and follow-on clinical plans.

Representative deliverables

Nonclinical development roadmap

Study sequence, dependencies, timing, and decision use.

Nonclinical gap analysis

Evidence gaps and risk levels.

Evidence dependency map

Relationships between nonclinical, CMC, and clinical evidence.

Nonclinical evidence package outline

Partner-facing nonclinical evidence structure.

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
Nonclinical Development RoadmapICH M3(R2), S6(R1), S9, S7A/S7B, M10Define timing and scope of nonclinical safety, TK/PK, and bioanalysis evidence.
Clinical Development RoadmapICH E6(R3), E8(R1), E9(R1), M12, M15Connect clinical study quality, estimands, DDI, and MIDD planning to the roadmap.
Evidence-based Decision FrameworkICH E8(R1), E9(R1), M15Define decision-quality evidence, model-informed evaluation, and documentation logic.

Core terms

Quick-win

A development approach that rapidly confirms a high-value opportunity.

Fast-fail

An approach that enables early discontinuation or redirection of weak paths.

Evidence package

A set of nonclinical, CMC, clinical pharmacology, and clinical evidence supporting a decision.

Decision point

A planned moment to decide whether to continue, modify, stop, expand, or partner.