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Running a long-term Phase III clinical trial is challenging. Now imagine doing two at the same time – each with over 1,200 patients, individual participation for more than a year, across 100+ sites worldwide.
That’s exactly what the SCOPE team recently accomplished.
Complexity was high from the start. Data flowed in from eCRFs, IVRS, eDiaries, central laboratories, imaging analysis units, and safety databases. Coordinating across multiple vendors and integrating these streams could have been overwhelming. But the team’s experience, focus, and risk-based monitoring strategy turned challenge into opportunity.
Over the course of the trials, SCOPE’s data management team:
· Processed ~200,000 data forms
· Verified >68,000 forms
· Managed >49,000 queries
· Reconciled >51,000 items
Even with massive datasets and multiple touchpoints, the team maintained continuous oversight. They streamlined data presentation for review, selected patients for medical review, and distributed coding tasks efficiently – all while keeping timelines tight.
The payoff? Just three weeks from Last Patient Last Visit to the Data Review Meeting, including monitoring visits, medical review, and full data reconciliation. Follow-up questions were resolved within 3 days, and no discrepancies were detected.
This demonstrates what SCOPE brings to complex clinical trials: intensive, proactive management that not only keeps studies on track but accelerates timelines while ensuring high-quality, reliable data.
Managing long-term, large-scale trials with multiple vendors and extensive datasets is no small feat. Yet SCOPE’s team proved that expert planning, meticulous execution, and rigorous quality processes make complexity manageable – and turn ambitious studies into success stories.
At the end of the day, these trials weren’t just completed – they were executed flawlessly, reaffirming that SCOPE transforms challenges into confident outcomes.
