Supporting a U.S. Sponsor's Phase III Parkinson's Disease Trial Across Asia-Pacific

Overview

A U.S.-based biopharma company focused on CNS therapies partnered with Novotech to lead Asia-Pacific delivery for two studies within a global Phase III Parkinson’s disease program. The program included a parent study assessing the efficacy, safety, and tolerability of a small molecule therapy in early Parkinson’s disease, alongside an open-label rollover study evaluating long-term safety.

With global recruitment timelines under pressure and no established APAC site strategy, the sponsor needed a regional CRO partner that could identify the most viable countries and sites, navigate protocol-specific assessment requirements, accelerate start-up, and deliver meaningful enrolment within a compressed timeframe.

Novotech developed and implemented a focused country and site strategy across South Korea, Taiwan, and Thailand. The team evaluated 25 sites and selected the eight with the strongest combination of qualified investigators, assessment readiness, patient access, and recruitment potential. By integrating regional regulatory, start-up, clinical operations, and recruitment expertise, Novotech enrolled 28 patients in approximately four months, achieving the sponsor’s APAC recruitment objective and helping maintain the timelines of the global Phase III program.

The Challenge

The sponsor needed to establish productive recruitment capacity in Asia-Pacific quickly. However, the protocol’s specialised assessment requirements significantly restricted the number of countries and sites able to participate.

Key challenges included:

• Validated translations of the required Parkinson’s disease assessment questionnaires were available only in selected markets, limiting the feasible regional footprint
• Each site required at least two certified raters for every specified assessment scale, substantially reducing the pool of eligible sites, particularly in Thailand
• Four related Parkinson’s disease protocols were being planned concurrently, requiring sites to be allocated according to investigator interest, qualifications, patient access, and recruitment priorities before the sponsor later discontinued two of the protocols
• The compressed recruitment window required coordinated start-up and enrolment delivery across three countries while maintaining assessment consistency and data integrity

The sponsor required more than additional sites. It needed a targeted regional strategy that could convert a constrained feasibility landscape into reliable enrolment within the required timeline.

Novotech’s Approach

Building a Viable APAC Country and Site Strategy

Novotech assessed the protocol requirements against country-level feasibility, including the availability of validated questionnaires, investigator qualifications, certified rater capacity, patient populations, and local site readiness.

Based on this assessment, Novotech recommended South Korea, Taiwan, and Thailand as the most viable countries for regional delivery. With no sponsor-nominated sites in APAC, Novotech approached and evaluated 25 potential sites across the three countries. Eight sites were selected based on their ability to meet the protocol requirements and contribute meaningful recruitment within the compressed study window.

Sites were also assessed against the requirements of the four related protocols and allocated according to investigator interest, site capability, patient access, and the sponsor’s recruitment priorities. This gave the sponsor a focused regional footprint centred on sites with the strongest potential to deliver.

Accelerating Site Readiness and Recruitment

Following site selection, Novotech led local regulatory submissions, study start-up, site activation, clinical operations, and project management across all three countries. The team coordinated training on the validated Parkinson’s disease assessment scales and study-specific procedures, helping ensure that investigators, certified raters, and site staff were prepared for consistent study delivery.

During recruitment, Novotech used weekly pre-screening reviews, close site communication, and targeted follow-up to give the sponsor timely visibility into patient identification and enrolment progress. Potential barriers were identified early and addressed directly with sites, helping sustain recruitment momentum throughout the four-month enrolment period.

Outcomes

Novotech achieved the sponsor’s APAC recruitment objective within the compressed delivery window, adding productive regional capacity to the global Phase III program.

Key outcomes included:

• 28 patients enrolled across eight APAC sites in approximately four months
• 18 patients enrolled across three sites in Thailand
• Six patients enrolled across two sites in Taiwan
• Four patients enrolled across three sites in South Korea
• Average recruitment rate of 0.875 patients per site per month
• Eight high-potential sites selected and activated from 25 sites evaluated
• Two global Phase III Parkinson’s disease studies supported across Asia-Pacific
• Complex start-up activities managed, including paper-scale questionnaires and training

By establishing a viable APAC footprint and translating that strategy into timely enrolment, Novotech helped the sponsor achieve its regional recruitment objectives, keep Asia-Pacific delivery on schedule, and maintain momentum across the broader global Phase III program.

Sponsor Quote

“Your team has always worked with such urgency and tenacity, and I appreciate the dedication and hard work you maintained through this last year. I am continually impressed by the Novotech team and am looking forward to closing out our SUPER successful study and program in late 2025/early 2026.”