To The Rescue – Getting A Phase I Oncology Study Back On Track
Source: INC Research/inVentiv Health
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.
access the Case Study!
Log In
Get unlimited access to:
Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue.
X
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.
Subscribe to Clinical Leader
X
Subscribe to Clinical Leader
This website uses cookies to ensure you get the best experience on our website. Learn more