From site initiation to first participant in just three days
- Healthy volunteer vaccine study
- Adults aged 60–85
- Melbourne, Australia
- 15 JanEthics submission
- 2 FebEthics approval
- 3 FebResearch agreement signed and site initiation visit
- 4 FebSite activated
- 6 FebFirst participant in
- 20 FebLast participant in: all 85 enrolled
- End MarSponsor's last-participant-in target
from site initiation visit (SIV) to first participant in (FPI)
participants enrolled within 14 days
ahead of the sponsor's last-participant-in target
from ethics submission to first participant in
Overview
Accelerating vaccine trial delivery
When a vaccine study required rapid site activation and accelerated enrolment, Paratus Clinical was engaged as an additional research site to support the next stage of the trial.
Working to a compressed timeline, our Melbourne team coordinated start-up activities, prepared recruitment and managed additional operational responsibilities to ensure the site was ready to begin enrolling participants immediately after activation.
The result
First participant in just three days after the site initiation visit, with all 85 participants enrolled within 14 days.
The sponsor required an additional clinical research site capable of activating quickly and delivering accelerated recruitment for a vaccine study involving healthy adults aged 60–85.
Beyond standard site responsibilities, Paratus Clinical was also tasked with managing activities typically coordinated by sponsors or central vendors, including laboratory kit preparation and supply, and study vendor contracting.
With an ambitious enrolment target and limited time for site start-up, the challenge was to accelerate multiple operational processes without compromising regulatory requirements or study readiness.
Healthy adults
aged 60–85
Vaccine study
already under way
Extra duties
lab kits & vendors
Paratus Clinical implemented a coordinated start-up and recruitment strategy, allowing key activities to progress simultaneously rather than sequentially.
- Parallel start-up activities: Ethics, contracting, vendor engagement and laboratory kit preparation were managed concurrently to reduce delays.
- Accelerated site activation: Ethics approval was secured the day before the site initiation visit, with the clinical trial research agreement executed on the day of the visit and activation completed the following day.
- Recruitment readiness: Potential participants were pre-identified ahead of activation, allowing screening and enrolment to commence promptly once the site was authorised to proceed.
- Integrated operational delivery: Internal teams coordinated additional vendor and laboratory responsibilities alongside standard clinical trial activities to support the compressed timeline.
This approach enabled the site to move rapidly from initiation to active participant enrolment.
Paratus Clinical achieved the full recruitment target ahead of the sponsor's planned timeline.
- 3 days from SIV to FPI: The first participant was enrolled and dosed just three days after the site initiation visit.
- 85 participants enrolled: The site's full allocation was achieved within 14 days of first participant in.
- 39 days ahead of target: Last participant in was achieved well before the sponsor's end-of-March deadline.
- 22 days from ethics submission to FPI: Rapid coordination of regulatory, operational and recruitment activities supported accelerated study delivery.
Healthy adults
aged 60–85
Vaccine study
already under way
Extra duties
lab kits & vendors
Conclusion
This case study demonstrates Paratus Clinical's ability to accelerate site activation, coordinate complex operational requirements and deliver recruitment outcomes within demanding study timelines.
By combining efficient start-up processes with proactive recruitment planning, Paratus Clinical supported the sponsor in achieving its enrolment objectives significantly ahead of schedule.
Looking for a clinical research partner in Australia?
From accelerated site activation to targeted participant recruitment, Paratus Clinical provides the operational expertise and site capabilities to support clinical trial delivery.
Research with purpose. Results with impact.