Our site was awarded a critical influenza vaccine trial with exceptionally tight timelines. This two-site study aimed to evaluate the vaccine’s efficacy and safety in 200 healthy volunteers, with each site responsible for recruiting and dosing 100 participants.
Study Overview
Objective:
- Evaluate the efficacy and safety of an Influenza vaccine.
Study Design:
- Same-day screening and dosing.
Population:
- 200 healthy volunteers (100 per site).
Timeline:
- Extremely tight recruitment and dosing schedule.
Challenge and Solutions
Rapid Recruitment:
- Leveraging our robust volunteer database, we swiftly identified and contacted potential participants. Within less than one week, we successfully recruited 120 subjects, surpassing our initial target.
Same-day Screening and Dosing:
- On the designated day, we screened 107 subjects, with 105 found eligible and successfully dosed. Our team implemented a highly efficient workflow, ensuring that all necessary screening procedures were completed accurately and promptly. Our efficiency not only met our site’s requirements but also supported the other site in achieving their enrollment targets.
Quality Control and Data Management:
- Our dedicated team performed thorough quality control (QC) on all participant charts on the same day of dosing. This proactive approach ensured that the information was clean and ready for immediate EDC entry, facilitating seamless data management and analysis.
Outcome
We achieved significant milestones in our recent study demonstrating remarkable enrollment
success by recruiting and screening 120 subjects in less than one week. Our dosing efficiency was equally impressive, with 107 subjects screened in a single day and 105 of them successfully dosed. We maintained high standards of data quality by completing QC on all charts the same day, ensuring clean data for EDC entry. Our efforts did not go unnoticed, as the sponsor expressed their gratitude for our team’s outstanding accomplishments and exceptional efficiency.
