Background

Since the onset of the global COVID-19 pandemic, the pharmaceutical industry has made tremendous efforts to develop effective treatments and vaccines. As such, there was a high demand for COVID-19-related drug development to be dynamic early into the pandemic.

A biotech sponsor based in China was conducting a clinical study on COVID-19 treatment in the United States and the Asia Pacific region, including China, in collaboration with a global contract research organization (CRO).

However, because of the quick changes in the pandemic's spread and the CRO's resource distribution, few sites were activated and only a small number of participants were recruited, even after six months of starting the study.

Assessing the situation, the sponsor decided to focus all clinical trial efforts in China and selected HiRO to assume full-service CRO responsibilities. Going into the trial, our team knew that both efficiency and quality were essential for the revival of this study.
 

Challenges and HiRO's Solutions

During this period, several key events took place: the shift from the global CRO to HiRO, the start of study site activations, and the enrollment of the first patient following the transition. However, this timeline faced an interruption due to the Lunar New Year, a week-long national holiday in January 2023.

In response to the sponsors' needs, HiRO quickly took action. After an initial discussion, HiRO formed a preliminary team made up of a project manager, regulatory experts, clinical operation staff, a medical director, and data scientists to understand the situation better and offer insights.

Only two weeks passed between the first discussion with the sponsor and the official launch of the project.  
 

Shifting Landscape

As vaccine and treatment development accelerated, the strategies for COVID-19 prevention and treatment kept evolving.

In response, the sponsor updated their approach and made changes to the study protocol.

While moving from a global to a local study seems straightforward, not all CROs possess a team that understands both the global context and local nuances in China. HiRO's team didn't just handle a vast amount of work; they also restructured the sites for better efficiency. Upon evaluating potential risks, HiRO's data scientists pinpointed issues in the existing system and revamped it without affecting the current study.

Managing Tight Timelines

As industry experts, the HiRO team are familiar with tight timelines.

Our streamlined service allowed for a quick full-service transition involving multiple functions and many third parties. From the outset, the HiRO project team maintained a clear vision of the overall project goal and ensured seamless communication with stakeholders at each critical decision point. The experienced project management team navigated the tight timeline with superior problem-solving skills. The bilingual team, proficient in both English and Mandarin, saved significant time and resources on translation and communication.

Outcomes

HiRO's flexible and creative high-standard practices allowed us to successfully rescue the study, achieving the key milestone twelve weeks ahead of schedule.

The IDMC (Independent Data Monitoring Committee) meeting for the first study milestone finished two weeks earlier than expected, and the meeting for the second milestone was completed twelve weeks in advance. The transition of all functions between the two CROs took only 5 weeks, without affecting site initiation or patient enrollment.

The sponsor was thrilled to receive crucial study data and favorable IDMC suggestions much earlier than anticipated.

Recognizing the myriad challenges and obstacles in this daunting rescue mission, the sponsor expressed their appreciation for HiRO’s outstanding performance with several thank-you messages.

[Testimonial is translated from Chinese and some information is censored]

“I am pleased to inform you that with the efforts of everyone in the HiRO team, the project has reached the second critical milestone of a total of ■ subjects! The completion of this milestone is nearly 2 weeks earlier than the original plan! And just 5 days later, today we have enrolled another ■ number of subjects! In the absence of a peak in the epidemic! On behalf of the Sponsor project team, I would like to express my sincere gratitude for the excellent performance of your team. Thank you for your team's high intensity work with frequent communication day and night over the past three months, and every team member has been striving for every second and every day; Especially the front-line peers who are pushing for every potential case for recruitment. Your efforts have ensured the early achievement of today's milestone.” – Biotech Sponsor

“We would like to express our gratitude to the HiRO Business Development team. Your efficiency, clinical expertise, and communication and coordination skills are admirable. Since the official KOM, the HiRO project team has been working non-stop. The first study site is initiated within 5 days from the KOM. In less than 2 months, the project team has completed countless tasks that it would be impossible to list all of them in this letter, those include initiation and handover of several dozen study sites within 20 days, as well as the entire project transition and protocol amendment. I would like to express my gratitude to the HiRO project team. Your capabilities, professionalism, determination and dedication to the project are all top-notch in the industry. Your proven ability of managing the project at global quality standards, while maintaining the flexibilities which are required by biotech like us, has affirmed our initial choice of making HiRO as a partner.” – Biotech Sponsor