Japan-Australia Clinical Trial Partnership Strategy

Australian Site Network Partnership

March 2026

Canopy + Remedy CRO

Preferred APAC Early-Phase Partner

60%+ Early-Phase Trials

Faster Ethics / CTN Pathway

Japan–APAC Development Bridge

Agenda

Strategic Rationale — Why Australia for a Japanese CRO

Specific Advantages for Remedy

Win–Win Value Model: Remedy · Site · Sponsor

Early-Stage Engagement Strategy & Tactics

Practical Proposal Outline

01

Strategic Rationale

Why Australia for a Japanese CRO

Early-Phase Hub

60%+ of Australian trials are Phase 1–2, ideal for first-in-human and proof-of-concept programs Japanese pharma wants to globalise.

Faster Regulatory Pathway

CTN/CTA ethics approvals are faster and more flexible than Japan, enabling rapid trial start-up.

Approachable Investigators

Australian PIs are open to direct CRO collaboration — Remedy acts as a bridge, not just a vendor.

De-risk Before Japan Phase 3

Australian PoC data accelerates programs before confirmatory studies in Japan, reducing PMDA risk.

Australian early-phase data strengthens your Japanese development and registration strategy.

Specific Advantages for Remedy

Australia as a Plug-In Module to Remedy's Japan Services

Fast Start-Up & Flexible Designs

Shorter ethics and site activation timelines vs Japan. Supports adaptive designs, early PK/PD, and dose-escalation studies.

Japan-Quality Data Standards

SOPs and monitoring practices aligned to Japanese data quality expectations. PMDA-compatible dictionary choices, visit schedules, and safety reporting.

Broader Recruiting Population

Strong oncology and complex-indication recruitment. Access to non-Japanese Asians and Caucasians to support global filings.

One-contract / one-governance model across sites. Remedy markets a simple, scalable Australia solution to Japanese clients.

Win–Win Value Model

<span style="color: #00B4D8; font-weight: 700;">Remedy</span> <span style="margin: 0 15px; opacity: 0.4;">|</span> Australian Site <span style="margin: 0 15px; opacity: 0.4;">|</span> Japanese Sponsor

Together: Japan + Australia = Faster, Lower-Risk Global Development

REMEDY CRO

<strong style="color: #FFFFFF; font-weight: 600;">Differentiated APAC footprint:</strong> Japan + Australia early-phase package

<strong style="color: #FFFFFF; font-weight: 600;">Lower delivery risk:</strong> pre-qualified site network reduces start-up time

<strong style="color: #FFFFFF; font-weight: 600;">Stronger RFI/RFP story:</strong> concrete Australian options at first engagement

JAPANESE SPONSORS

Faster PoC then smooth transition to Japan Phase 2/3

One primary interface (Remedy) for both Japan & Australian execution

PMDA expertise + English-speaking Australian investigators

AUSTRALIAN SITE

Consistent inbound Japanese work via Remedy

Early scientific and operational design involvement

Predictable pipeline, not ad-hoc site selection

Early-Stage Engagement Strategy

Getting into Remedy's First Client Conversation

A. Joint Positioning & Materials

Co-branded capabilities pack with Remedy's Japan strengths

"The Australian Advantage" slide: early-phase focus, rapid CTN, oncology experience

Combined: "Japan–Australia Integrated Development Pathway" (FIH → dose expansion → Phase 3)

Standard early-BD talking points ready for first client call

B. Operational Frameworks

Master Collaboration Agreement (MCA): pre-negotiated commercial terms & QMS interfaces

Enables Remedy to quote Australian cost/timeline at RFP without fresh negotiation

Standardised study start-up playbook: feasibility templates, start-up assumptions, recruitment projections

Clear escalation pathways between Australia and Remedy's PM

C. BD & Relationship Building

Joint webinars in Japan: "Using Australian early-phase data to strengthen PMDA interactions"

Targeted KOL engagement

Australian PI connections to Japanese investigators via Remedy

Goal: Australian capability introduced in Remedy's very first conversation with Japanese clients

Japan–Australia Integrated Development Pathway

First-in-Human (FIH)

Phase 1 in Australia. Rapid ethics/CTN approval. Early PK/PD and dose escalation.

Proof of Concept (PoC)

Phase 1b/2a. Oncology or complex indication. Recruit non-Japanese Asian + Caucasian populations.

Dose Expansion / Bridging

Expand to Japanese sites. PMDA-aligned data package. Unified Remedy project management.

Confirmatory Phase 3

PMDA registration-ready data. Remedy manages Japan execution. Full development lifecycle complete.

Managed by Remedy — single point of contact for Japanese sponsors

Australian data de-risks and accelerates PMDA submission

Practical Proposal Outline

Business Plan Structure for Remedy Partnership

01

Executive Summary

Strategic rationale for Remedy–Australia partnership. How it helps Remedy attract and retain Japanese sponsors: speed, global reach, risk reduction.

02

Market & Regulatory Context

Japan: quality-focused, late-phase emphasis, PMDA expectations. Australia: early-phase, fast CTN/ethics, CRO-as-bridge model.

03

Service Model & Scope

Site/network capabilities: indications, phases, start-up SLAs, data standards. Remedy's role: single point of contact, unified PM, consolidated reporting.

04

Commercial & Governance Framework

Win-win table: Speed / Quality / Simplicity. Preferred-partner status. Volume-based discounts after set number of joint studies.

05

Early-Engagement Playbook

4-step process: Identify opportunity → Share Australia Option Sheet → Rapid feasibility → Unified Japan–Australia proposal.

Early-Engagement Playbook

From First Japanese Client Call to Study Award

Identify Opportunity

Remedy identifies a Japanese client program where Australian early-phase or additional recruitment adds value.

Share Australia Option Sheet

Remedy sends a 2–3 page co-branded 'Australia Option Sheet' with timelines, cost ranges, and feasibility assumptions.

Rapid Country Feasibility

Australian site/network produces country-level feasibility response within agreed SLA.

Unified Japan–Australia Proposal

Remedy integrates Australia data into a single cohesive Japan–Australia package presented to the Japanese sponsor.

Pre-negotiated MCA means no fresh contract negotiation — Remedy can respond faster than competitors

Let's Build the Partnership

Canopy × Remedy CRO — Japan + Australia as One

Agree Preferred-Partner Framework

Execute MCA and governance terms

Co-Develop Capabilities Materials

Joint deck and Australia Option Sheet

Schedule First Joint BD Activity

Joint webinar or targeted Japanese KOL outreach

Faster proof-of-concept. Smoother Japan integration. One trusted partner.

Canopy + Remedy CRO | March 2026