Case Study: Optimizing Medical Device Trials
A medical device CRO integrated RTSM with EDC to manage supply and capture device performance data. Remote monitoring via Tele-Health reduced patient dropouts by 25% and ensured smoother regulatory approval.
Background
Oncology clinical trials are among the most complex and resource-intensive studies in the Life Sciences Industry. A leading global pharmaceutical company was conducting multiple oncology studies across 15 countries. The trials involved thousands of participants, strict regulatory oversight, and high data management demands.
The company faced major challenges including:
Solution
The Clinical Trial Software was deployed to digitize and unify trial operations. Key components included:
- eConsent – Enabled participants to review and sign consent forms electronically, improving understanding and compliance.
- ePRO – Allowed patients to directly report symptoms and outcomes using secure web and mobile devices.
- EDC (Electronic Data Capture) – Provided real-time centralized data collection from all participating trial sites.
- Analytics Dashboard – Delivered real-time insights for sponsors, investigators, and CRO partners to track trial performance.
Results
The implementation of the Clinical Trial Software led to measurable improvements:
Simplified eConsent and remote reporting increased participant retention.
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.