More than 40% of all clinical trials currently running for FDA or EMA approval have either missed key deadlines and milestones, or are in danger of missing key deadlines. Biorasi is an expert at putting trials back on track quickly while maintaining quality and data integrity.
Many Rescues, Never Rescued
Clinical trials fail for a wide variety of reasons including inadequate planning, flawed study design, poor site compliance and training, slow patient enrollment, deficient monitoring, or a lack of timely communication among stakeholders. Fortunately, most trials can be saved if key indicators are closely monitored, which fosters early intervention and resolution. With continual assessment of the key metrics of a trial which effect time, quality, and cost, Biorasi has become a go-to in the field for saving clinical studies that have gone off timeline and budget.
Biorasi has a long track record of being able to integrate into trials as a rescue CRO and right a tilting ship. We have worked both as a supplementary CRO, adding our strengths to a trial’s incumbent CRO, as well as by assuming primary study management responsibility from the incumbent CRO. This flexibility allows us to apply maximum force towards ensuring your trial’s success in the most efficient way possible.
Biorasi also offers independent trial auditing services, in the form of trial health assessments, to help sponsors make the decision on how best to return the study to a successful timeline. Biorasi will review trial milestones, processes, and progress, conduct a gap analysis and generate a full report highlighting risk mitigation methods and best practices for ensuring a successful study completion. Knowing the condition of the study and its probability of successful completion, especially if evaluated early in the process, can dramatically improve the outcome, and save sponsors millions of dollars and months of time.