Case Study: Late Phase COVID-Flu Vaccine Trial 2024

When a global biotech sponsor needed to run a multi-site, late-phase trial for a COVID-Flu combination vaccine in New Zealand, we achieved top results by responding with speed, flexibility, and care.

Despite challenges, no matter the "ask", we delivered unrivalled performance given our targeted recruitment and streamlined processes.

The Challenge

Originally designed as a multi-site, large-scale, late-phase vaccine trial, Optimal had 800+ patients aged 65+ booked weeks before FPI.

Several unforeseen challenges emerged before activation, including:

• Last-minute protocol changes that significantly reduced the sample size
• Changing FPI dates – resulting in possible attrition from pre-booked patients
• Once the trial was officially activated, there was a very short window for recruitment and randomisation

Our Approach

Due to our extensive experience and seasoned staff, we were able to adapt to trial protocol changes quickly.

Customer First Approach

• Clear communication kept patients engaged from day one. We made sure everyone who was pre-screened felt informed and included. Whether it was a phone call, an email, or a quick chat, we kept the lines open so no one felt left out. That consistent communication built trust and kept people engaged.
• Once the study began, we made participation easy: flexible scheduling, help with transportation, even light refreshments after appointments. When people feel supported, they stay involved.

Smart use of existing resources

Starting strong made all the difference. We didn't have to start from scratch because we built a strong participant database early on. When a shift in the study’s start date led to some drop-off in patient recruitment, we quickly filled the additional patients required by tapping into our database, local community networks, and targeted advertising.

Pre-screening and preparation

Pre-screening set us up for a fast start. Before the site went live, we re-confirmed eligibility for every participant. That way, when activation day came, we were ready to hit the ground running. This helped us avoid delays and kept momentum strong from day one.

• Responsive and Ready:
  Whether it’s a timeline shift or updates to participant criteria, our team knows how to adapt quickly and keep things moving. For this trial, our ability to stay flexible and respond in real time meant we could start up fast, maintain momentum, and deliver strong recruitment outcomes.
• Targeted Recruitment
  Targeted recruitment kept us on track. We leaned on our existing database and strong community relationships and filled any remaining gaps with focused advertising.
  With over 800 participants already registered, we had a solid head start—making it easier to adapt when timelines shifted.
• Focusing on the patient experience
  A better experience kept patients engaged. From clear communication to thoughtful touches - like a friendly face at check-in or a cup of tea after a visit - we focused on making people feel welcome and cared for. These small moments added up, helping build trust and keeping participants involved throughout the study.
• Excellence in Execution
  Our streamlined processes and quality systems ensured reliable data throughout the trial. With ISO 9001 certification and a recent successful FDA inspection behind us, sponsors can count on us for quality that meets international standards—every time.

This trial showed that change is part of the process. It highlighted how agility, experience, and thoughtful planning—combined with a flexible, people-first approach—can turn challenges into progress.

Our team’s expertise helped us adapt quickly, keep things moving, and stay focused on what mattered most: the participants.

What made this trial successful wasn’t one big moment—it was the team’s steady, day-to-day work and dedication that kept everything on track from start to finish.

Let’s deliver what matters, together.