Case Study

Medical Review & Oversight Success Story

Improving Patient Safety and Reducing Risk

A streamlined medical review process is a game-changer for one midmarket pharmaceutical company.

Overview

Slow safety signal detection, an inability to drill down to root causes, and a cumbersome manual reconciliation process for serious adverse events were frustrating the data management team at a midmarket biotech company.

Challenge

The sponsor had issues visualizing full patient profiles and was unable to spot trends that led to adverse events. The inability to share data and resolve queries was bogging down studies.

Solution

Saama’s automated data aggregation, automated alerts, and real-time performance dashboards created immediate improvements. The sponsor continues to rely on Saama’s Clinical Insights and Operations Insights solutions to keep studies on track.

Results

After implementing these solutions, study teams saved 15 hours per month resolving queries, SAE reconciliation went from three months to one week, and key stakeholders were able to make better-informed decisions based on real-time information. In addition to impressive productivity benefits, safety risk was reduced and compliance improved across studies.

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Primary Business
Pharmaceuticals/Biotech
Headquarters
San Francisco
Employees
500
Annual Revenue
$1.00B
Trial Portfolio
3 Studies
1 CROs
7 Data Feeds
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“We deployed the solution on some of our most important, high-profile studies. Right away we started to realize increased efficiencies.”

–Head of Clinical Data Management

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