Case Study: Streamlining Rare Disease Trials
A CRO running a rare disease trial used Participant Tracker and eConsent to optimize patient enrollment across multiple countries. Transparent oversight led to 100% recruitment completion on time and improved sponsor satisfaction.
Background
Rare disease clinical trials face unique challenges due to limited patient populations, geographic dispersion, and complex regulatory requirements. A mid-sized biopharma company conducting a Phase II trial for a genetic rare disease sought a solution to improve patient recruitment, ensure data quality, and accelerate study timelines while maintaining compliance.
- Patient Recruitment Barriers – Difficulty identifying eligible participants across multiple countries.
- High Dropout Risk – Patients were required to travel long distances to sites, affecting retention.
- Data Fragmentation – Clinical data was collected through multiple systems, leading to inefficiencies.
- Regulatory Oversight – The sponsor needed full audit trails and real-time visibility for regulators.
Solution
The sponsor implemented our Clinical Trial Software platform, leveraging the following modules:
- eConsent – Enabled patients to review and sign consent forms remotely, increasing recruitment efficiency.
- Tele-Health – Facilitated secure virtual visits, reducing the need for site travel.
- ePRO – Allowed patients to directly report outcomes via mobile devices, ensuring accurate real-time data capture.
- RTSM – Automated supply chain management to prevent delays in drug availability across sites.
- Centralized Participant Tracker – Gave sponsors real-time oversight of screening and enrollment activity.
Results
The implementation of the Clinical Trial Software led to measurable improvements:
Expanded patient access through remote consent and vendor integration.
Real-time data capture and monitoring accelerated recruitment and reduced delays in interim analysis.
Automated workflows minimized manual errors and standardized reporting across global trial sites.
ePRO allowed patients to conveniently share outcomes from home, reducing site visit burden.