Case Study

Scaling Clinical Research with an Automated Duplicate-Prevention Registry and Data Quality Workflows

Client

Industry

Region

North America, Asia Pacific, South America, EU (HIPAA & GDPR Compliant)

Overview

CenExel, a leading clinical research organization operating across multiple regions, faced serious risks caused by duplicate and professional subjects entering multiple studies under different identities. This led to compromised data integrity, regulatory concerns, and delays in study timelines. They also needed reliable Study/Protocol-wise visit tracking and a controlled process ensuring that only trained and certified site users could enter participant data.

To address these challenges, Vivasoft Ltd. delivered two integrated, high-security solutions.

Vivasoft Ltd. engineered CTSdatabase to serve as a centralized clinical trial subject registry. They designed it specifically to detect and prevent duplicate subjects without exposing private or identifiable information.

Anonymity by Design: Vivasoft Ltd. ensured the system maintains complete subject anonymity while identifying attempts by professional subjects to alter their presentation.
Investigative Insights: They provided investigators with a full history of a subject’s past study participation. They delivered actionable match insights that enable confident enrollment decisions.
Access Control: Vivasoft Ltd. enforced site-user training and certification requirements before any subject data can be entered.

Alongside this, Vivasoft Ltd. developed the CenExel Data Quality Program. They strengthened oversight of Study/Protocol-wise visit data and automated quality-control workflows. They significantly improved data accuracy and overall operational reliability across sites. Together, these platforms transformed the client’s clinical operations.

Technologies Used

Dot Net