More than 40% of all clinical trials currently running for FDA or EMA approval have either already missed key deadlines and milestones, or are in danger of missing key deadlines. Biorasi is an expert at trial rescue, putting trials back on track quickly while maintaining quality and data integrity.
Many Rescues, Never Rescued
Clinical studies experience problems 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 rescued if key indicators are closely monitored, which fosters early intervention and resolution. Because of our unparalleled strength in complex project management, coupled with more than a decade of experience in study rescue, Biorasi has become the go-to partner for rescuing problematic studies.
Biorasi has a long track record of being able to integrate into trials as a rescue CRO and right faltering programs. We have worked both as an integratedCRO, adding our strengths to a trial’s incumbent CRO, as well as as a transition CRO, by assuming primary study management responsibility from the incumbent organization. This flexibility allows us to tailor our trial rescue solution to best meet the needs of your study, and maximize the value Biorasi provides our sponsors.
Biorasi also offers independent trial auditing services, in the form of study health assessments, to help sponsors make the decision on how best to return the study to a position of success. In a study health assessment, 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 illuminate paths that will dramatically improve the outcome, and save sponsors precious money and time.
"One of the rarest events, where we had to communicate [to Biorasi] to stop the screening rather than boost it."VP of Global Clinical Development, Top Specialty Pharma
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A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. These delays are a...