Client Background
The client is one of the largest Research Consulting Organizations (RCOs), providing end-to-end regulatory, clinical, and compliance services to pharmaceutical, biotechnology, and medical device industries.
Client Need
The client faced challenges due to inconsistent data exchange between their Oracle Argus system and their CRO's submission systems, which led to inaccurate regulatory submissions. Additionally, they also faced a slow, manual reconciliation process, risking fines and reputation damage.
Solution
We implemented an automated solution that drastically reduced the reconciliation process from weeks to hours. This proactively identified discrepancies between sponsor and CRO systems and enabled seamless follow-up submissions, ensuring adherence to strict regulatory timelines.
Realized Benefits
45% operational efficiency gain
$ 4 M+ savings in annual costs
Timely submissions saved millions of dollars, ensured regulatory compliance, and protected brand reputation
Tools & Technologies
Oracle
Python
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