Clinical Case Study: Clinical Trial Management for Worldwide Phase III Clinical Study

Challenge icon

The Challenge

The client hired three CRO’s to conduct worldwide phase III clinical study in 9 countries, with 600 patients, at 100 centers.

Innovenn provided virtual clinical management team for oversight, central coordination, defined communication practices, team training, accountability and standardized tracking and reporting.

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What We Did

  • Reviewed vendor contracts, clarifying scope of work and identified gaps
  • Established roles/responsibilities concurrently with client, CRO, and vendors
  • Implemented standard tracking tools and processes to monitor timeliness and quality of study activities, ensuring GCP/ICH compliance
  • Prioritized countries’ and sites’ ability to complete required steps for drug shipment and start-up
  • Monitored patient enrollment with site enrollment plans and implementation of CRO monitoring visits/recruitment and retention strategies
  • Planned and implemented global site communication webinars ensuring investigational sites were motivated and informed throughout the trial
  • Established and maintained risk identification and mitigation plan tracking tool
  • Attended weekly team meetings with key vendors and CRO’s with minutes and actionable follow-up items
  • Team members used weekly study overview dashboards to update client senior management
  • Tracked and maintained detailed project plans with baseline and actual milestone dates and reviewed against contract to assess potential delays or contract scope changes
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Results Delivered

  • Ongoing data quality review identified (re)training opportunities
  • Provided information and minutes from a rigorous “lessons learned” meeting with all stakeholders informed process revisions for future projects and SOP updates
  • Enrollment enhancement tactics were implemented based on patient and site enrollment plans
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Key Outcomes

  • Strong partnership formed across CRO’s
  • Each region successfully achieved defined milestones
  • Rigorous documentation supported study audits by WW regulatory agencies
  • Project completed 2 months early
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Contact Us
Contact Innovenn

Global reach from Wisconsin HQ. Serving clients in the US, EU, UK & Canada

6410  Enterprise Lane
Suite 230
Madison, WI 53719

608-203-9748

info@innovenn.com

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