Supporting Phase II Celiac Disease Expansion from APAC to the U.S.

Overview

A U.S.-based clinical-stage biotech company was conducting a Phase II celiac disease trial across Australia and New Zealand. After Novotech established delivery in both countries, the sponsor selected Novotech to support the study’s expansion into the United States within a dual-CRO model.

When the U.S. scope was added in July 2025, Novotech was managing 21 sites across Australia and New Zealand. The challenge was to add U.S. sites and clinical delivery to an active study while keeping the new region aligned with the broader study plan, timelines and recruitment objectives.

The Challenge

The sponsor needed to add productive U.S. sites to a Phase II study across Australia and New Zealand that was already underway. The expansion required more than simply identifying additional sites.

Three priorities shaped the US strategy

• Finding the right sites: Sites needed access to eligible celiac disease patients and the operational readiness to execute the protocol. Recruitment potential had to be considered alongside screening, eligibility and endpoint requirements.
• Moving quickly: Site identification, regulatory preparation and activation needed to progress quickly enough for U.S. sites to contribute within the existing study timeline.
• Integrating delivery: The U.S. expansion had to fit within an established dual-CRO model, with clear coordination across regional operations, project management and data delivery.

The sponsor therefore needed a targeted U.S. expansion strategy that could add capacity without disrupting an active multiregional study.

Novotech’s Approach

Using Patient Advocacy Insight to Strengthen Site Selection

Novotech engaged an established celiac disease patient advocacy organization to inform U.S. site identification and recruitment planning. Its knowledge of the celiac disease clinical and patient communities helped focus feasibility and site outreach on locations with credible recruitment potential.

Novotech combined these insights with its assessment of site readiness, participant access and protocol requirements. This gave the sponsor a more targeted basis for selecting U.S. sites rather than relying on site availability or historical recruitment data alone.

Connecting Regional and Global Delivery

A New Zealand-based global project manager with significant U.S. operational experience led Novotech’s responsibilities across Australia, New Zealand and the United States. A U.S.-based clinical lead supported local start-up, site management and clinical delivery.

The team coordinated Novotech’s project management, regulatory, clinical and data activities within the wider dual-CRO model. As U.S. sites were introduced, Novotech also supported replanning to keep regional decisions, dependencies and timelines connected to the overall study plan.

This structure allowed the sponsor to add a new geography without managing it as a separate regional program.

Supporting Sites Beyond Activation

Novotech’s support continued once U.S. sites were activated.

The team worked directly with sites as they moved through screening and dosing, using regular communication and site-level follow-up to identify issues early and maintain recruitment activity.

This was particularly important as newly activated U.S. sites began contributing alongside the established Australia and New Zealand network, which continued to drive the majority of enrolment from Novotech-managed sites.

Outcomes

Novotech successfully established U.S. clinical delivery within the active Phase II study while continuing to manage the established Australia and New Zealand network.

The expansion gave the sponsor additional U.S. site and recruitment capacity within a coordinated multiregional delivery model rather than creating a separate regional workstream.

From One Study to a Broader Partnership

The celiac disease study formed part of a broader relationship that began in 2024 and expanded across indications, phases and geographies.

December 2024: Phase Ib vitiligo study, the first study awarded to Novotech

2025: Phase II celiac disease study, subsequently expanded to include U.S. delivery

2025: Phase Ib alopecia study

2026: Phase I healthy volunteer studies

Across these studies, the sponsor expanded Novotech’s role from studies centered in Australia and New Zealand to programs incorporating U.S. clinical delivery. Sponsor feedback has highlighted Novotech’s responsiveness, rapid start-up and collaborative approach, with continued interest in working together on future Phase II and Phase III programs.

The progression from an initial Phase Ib study to multiregional Phase II delivery and additional clinical development programs demonstrates how successful execution can create confidence to expand a CRO partnership.

For the sponsor, the value extended beyond adding U.S. capacity to one study. Novotech helped integrate a new region into an active program while maintaining momentum across the established Australia and New Zealand network. As the sponsor’s development needs expanded, so did Novotech’s role—across studies, indications, phases and geographies.