Improving Patient Safety and Reducing Risk
A streamlined medical review process is a game-changer for one midmarket pharmaceutical company.
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.
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.
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.
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.
“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