Case Study Background
A sponsor had contracted with two CRO’s to manage several Phase 3 global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) clinical studies. The study consisted of 270 sites in 8 countries with target enrollment of 2,100 patients.
A few months after the trials started, the sponsor became painfully aware that the CRO’s were not able to effectively manage the trials, as only 50% of the sites were on schedule; nor did the sponsor have the internal resources to manage the CRO’s to the degree necessary to diagnose the problem and implement a corrective action plan.
The sponsor knew that InClin had a wealth of experience in ABSSSI trials and called on InClin experts to join their clinical team and help get the study on schedule.
- Perform a diagnostic root cause analysis
- Collect and evaluate study metrics
- Understand what had been done, when tasks were done, by whom, and the quality of the work performed to date
- Evaluation of the processes being used to manage the study was performed for each region
- Evaluation of the CRO study team’s expertise and experience to ensure the right team was working on the study
InClin’s Actions Taken:
- InClin initiated a series of problem-solving meetings with the sponsor and the CRO. These meetings focused on open and honest communication so that everyone understood what had happened in the past, what needed to change and who was going to be responsible to drive the necessary change
- InClin created a corrective action plan and secured operational agreements with the CRO in the targeted regions
- InClin representatives traveled to each region meeting directly with the local CRO study team , the Principal Investigator and his staff to communicate and coordinate necessary changes
- In some countries, inexperienced CRO staff was the cause for delays. For these regions, InClin provided experienced clinical teams that took over the project and executed the study plans
- The designated CRO continued working in regions where enrollment was on time
- Site activation milestones were met
- Within two months enrollment metrics began to improve
- By the fourth month the trials were back on schedule
- Trials were finished on time
- Successful sponsor audit
- NDA and EMA approvals