Case Study: Efficient Vaccine Development
A global pharmaceutical company used Clinical Trial Software to manage oncology trials across 15 countries. By implementing eConsent and ePRO, the sponsor reduced patient dropouts by 30% and improved protocol compliance. Real-time data monitoring shortened trial timelines by nearly 20%.
Background
A leading biotechnology company embarked on the urgent development of a novel vaccine during a global health crisis. The study involved multiple trial phases with thousands of participants spread across different geographies. Rapid timelines, complex regulatory requirements, and the need for transparent safety monitoring created significant operational challenges.
Key challenges included:
- Managing large-scale participant enrollment and retention in record time
- Collecting and harmonizing safety and efficacy data across multiple regions
- Ensuring full regulatory compliance with accelerated review processes
- Minimizing operational delays caused by manual trial supply and monitoring workflows
Solution
The sponsor deployed our eTrackTrial Clinical Trial Software Suite, integrating modules designed to streamline every stage of the vaccine trial:
- Participant Tracker – Centralized recruitment, screening, and enrollment across diverse trial sites to accelerate recruitment timelines.
- EDC (Electronic Data Capture) – Real-time data collection and monitoring ensured accuracy and consistency of clinical outcomes globally.
- RTSM (Randomization and Trial Supply Management) – Automated supply chain and resupply algorithms ensured efficient distribution of investigational vaccines.
- Tele-Health – Enabled virtual patient visits, remote monitoring, and safety follow-ups to reduce site burden and improve accessibility.
- Compliance & Audit Trails – Automated record-keeping supported rapid submissions to health authorities worldwide.
Results
The implementation of the Clinical Trial Software led to substantial gains:
Participant Tracker streamlined patient enrollment and engagement across global regions.
Tele-Health and remote monitoring reduced physical visits and manual data entry.
RTSM ensured uninterrupted vaccine supply, reducing wastage and delays.
Full audit trails and compliance features enabled seamless collaboration with regulatory authorities.
By implementing our Clinical Trial Software Suite, the sponsor successfully accelerated vaccine development timelines while ensuring safety, compliance, and patient-centric engagement. This case highlights the power of digital trial solutions in bringing critical vaccines to market faster and more efficiently.
