Clinical Trial Rescue Services
At ESTERN Medical CRO Group, we know many issues can arise during the course of a clinical trial; timelines don’t get or met, data isn’t cleaned properly, sponsor resources get taken away from the study team, the diverse regulatory agencies halts the trial for lack of expected results, or sometimes a fresh outlook can put a trial back on track. ESTERN Medical is well experienced in rescuing a clinical trial programs.
The most frequent situations where we are called upon to rescue a trial include:
- Another Fresh Experience & Opinion
- Re-Balance Work Overload
- Accelerate New Timelines
- Poor History of Performance
- To Turn Around with New Performance
- To Execute a Corrective Action & Strategy
ESTERN Medical assists its clients with emergency site monitoring, immediate data management assistance, creative post analysis, new critical thinking.
Every study has its difficulties and sometimes, despite the best efforts, a clinical trial is not proceeding as planned. As clinical trials are complex many issues can arise and jeopardize your development program – poor site compliance, inadequate expertise, or lack of resources. No matter the reason, ESTERN Medical CRO Group will help you get your study back on track. Our primary concern is maintaining data integrity.
Your study needs Clinical Trial Rescue Service?
In the course of a clinical trial, many issues can come up. In spite of careful preparation for study execution, the unexpected can always happen. If you start managing your study internally, you might discover that you do not have enough resources or required expertise. Timelines are not met because resources are taken away from the study team. When project deadlines are accelerated there might be a need for increased clinical services like monitoring or site management. Perhaps another CRO you have chosen is no longer able to fulfill your expectations or needs.
When your clinical trial has significant operational issues, it is time to bring in a new team of experts who have the experience to analyze the problems and provide quick and proper corrective action. ESTERN Medical CRO focus on quality and expertise is the key to resolve your project problems across Latin America.
CAPA: Corrective and Preventive Action
Whether you are experiencing problems with quality, compliance, resources and/or timelines, ESTERN CRO offers a rescue service for any aspect of your clinical trial. Each study is unique and therefore every rescue is different. After a detailed root cause analysis of the problems our clinical trial team develops and implements a customized corrective and preventive action plan to resolve the current issues and prevent the recurrence of the same problem.
ESTERN Medical CRO, offers rescue service for your entire trial or any aspect of your trial:
- Issue analysis and solutions
- Study management oversight
- Management of vendors
- Co-monitoring as an additional training tool
- Emergency or increased site monitoring
- Emergency site auditing
- Data analysis
- CAPA (Corrective and Preventive Action) plans and implementation
While we can’t guarantee that we can save your study, our past success with clinical trial rescue is an excellent testimonial and predictor for the future.