SERVICES

Preclinical support from strategic planning to scientific interpretation.

Services can be commissioned individually or combined into an integrated workstream.

01

SERVICE

Preclinical Development Strategy

Translate program objectives into a structured roadmap with defined evidence needs, priorities, dependencies and decision points.

Typical scope

  • Review of current status
  • Scientific and operational gap analysis
  • Evidence-priority mapping
  • Study sequencing
  • Risk assessment
  • Decision criteria
  • Scenario planning
  • Development-roadmap preparation

Purpose

Identify the most informative and proportionate path for the program.

02

SERVICE

Study Design and Protocol Review

Develop or independently review study concepts, models, endpoints, controls, dose rationale and acceptance criteria.

Typical scope

  • Scientific-question definition
  • Model-selection rationale
  • Endpoint and control strategy
  • Dose and exposure rationale
  • Sampling and analysis planning
  • Acceptance criteria
  • Feasibility and risk review

Purpose

Ensure the design can answer the intended question with sufficient confidence.

03

SERVICE

CRO and Vendor Selection

Identify suitable providers, structure requests for proposal and compare scientific fit, readiness, timing and cost.

Typical scope

  • Provider landscape review
  • RFI and RFP preparation
  • Capability screening
  • Proposal normalisation
  • Scientific comparison
  • Scope-gap identification
  • Risk-adjusted recommendation
  • Kickoff support

Purpose

Select for scientific fit, operational reliability, data quality, timing and value—not price alone.

04

SERVICE

Study Oversight and Project Management

Maintain scientific and operational alignment from kickoff through data delivery, issue management and milestone review.

Typical scope

  • Kickoff preparation
  • Roles and responsibilities
  • Milestone planning
  • Provider communication
  • Protocol-change assessment
  • Deviation review
  • Risk escalation
  • Deliverable review

Purpose

Provide a consistent scientific and operational interface between sponsor and contributors.

05

SERVICE

Data Review and Scientific Interpretation

Assess data quality, integrate findings across workstreams and clarify implications for further development.

Typical scope

  • Data quality and completeness
  • Cross-study comparison
  • Exposure-response interpretation
  • Alternative-explanation analysis
  • Evidence-strength assessment
  • Gap identification
  • Development implications

Purpose

Distinguish observed findings, supported conclusions, unresolved questions and working hypotheses.

06

SERVICE

Scientific Due Diligence

Provide an independent assessment of scientific rationale, evidence quality, development assumptions, risks and remaining gaps.

Typical scope

  • Scientific rationale
  • Target and mechanism
  • Evidence quality
  • Model relevance
  • Translational logic
  • Development gaps
  • Risk classification
  • Scenario analysis

Purpose

Provide scientific analysis without replacing investment, legal or financial advice.

07

SERVICE

Troubleshooting and Program Rescue

Investigate underperforming studies, identify probable causes and define a proportionate recovery plan.

Typical scope

  • Study-history reconstruction
  • Protocol and execution review
  • Assay and model suitability
  • Root-cause hypotheses
  • Corrective-action planning
  • Repeat-study decision support
  • Recovery roadmap

Purpose

Diagnose before repeating, then define a proportionate recovery plan.

08

SERVICE

Fractional Preclinical Leadership

Add flexible senior-level scientific coordination for a defined period or development objective.

Typical scope

  • Program coordination
  • Vendor management
  • Development planning
  • Critical-document review
  • Risk and priority management
  • Temporary coverage
  • Structured handover

Purpose

Agree scope, time commitment, decision authority and deliverables before work begins.

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Describe the program, the immediate challenge and the decision you need to make.

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