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Accelerating a complex global cardiovascular outcomes trial through coordinated execution

Download this case study to learn how early alignment across CRO, clinical supply, and central laboratory capabilities helped keep a large global study on track as site activation and enrollment moved ahead of plan.

Managing a complex clinical trial is challenging at any scale. But when a midsized biotech company expanded from rare disease therapeutics into larger, more prevalent indications, its most ambitious study yet raised the stakes considerably.

The cardiovascular outcomes trial spanned 1,500 sites across 35 countries with a target enrollment of 11,000 patients. To keep the program moving, the company needed to accelerate site activation and patient enrollment, while keeping clinical supply and central lab activities aligned with faster-moving timelines.

Acceleration through integration: Streamlining clinical trial execution

Thermo Fisher Scientific brought together CRO, clinical supply, and central laboratory capabilities to help the customer streamline execution across the study. A sampling of the results included:

  • First site activated (FSA): 4 days ahead of plan
  • 50% of sites activated 5 months early
  • First patient in (FPI): 1 month ahead of plan
  • 25% of subjects enrolled 7 months early

Download the case study to see how an integrated approach helped the biotech begin recruiting patients sooner and maintain momentum on a strategically important cardiovascular program—while also reducing unnecessary lab kit waste.

Thermo Fisher Scientific - Accelerating Complex Global Cardiovascular Outcomes Trial