To The Rescue – Getting A Phase I Oncology Study Back On Track

A small, oncology-focused biotech was experiencing significant data, safety, vendor and monitoring issues in its Phase I programs that were worsening with time. The US biotech company needed a new outsourcing partner to quickly and effectively rescue its Phase I programs and get them back on track.

Beginning with risk and study status analysis, we developed a 90-day plan for assessing, transitioning and executing the rescue. The plan addressed the operational gaps, un-reported areas of risk, and data bottlenecks. Highlights of our multi-faceted solution include:

• Collected all missing lab reference ranges for the previous 15 months, outstanding SAEs (some as old as 26 months) and data that was two-and-a-half years behind with an error rate over 75% in five key data areas.
• Requested all sites provide additional baseline data gathered from existing lab and BMA reports dating back one year.
• Worked with vendors (ECG, core lab, data and safety) to resolve issues that were resulting in inaccurate and late data.
• Retrained existing site staff and added coordinators, data managers, nurses and Investigators so that all sites were adequately staffed.
• Added an additional site for Study B for a single compassionate use subject.