Clinical Study Rescue
Biorasi has a long track record of being able to right faltering clinical trial programs. Most trials can be rescued if key indicators are identified and early intervention leads to resolution. With a decade of experience in study rescue and our expertise with complex trials, Biorasi has become the go-to partner for rescuing problematic studies.
Is your trial in danger?
More than 30% of all clinical trials currently running for FDA or EMA approvals experience issues missing deadlines or milestones, as well as a wide variety of other issues. Download our white paper “3 Measures to Overcome Operational Failures”.
- Study design issues
- Data quality problems
- Budget overruns
- Logistics failures
- Timeline delays
What Makes Biorasi so Successful in Rescue?
Learn more about our Study Health Assessment
Biorasi offers a confidential Trial Study Health Check that requires no commitment and completed in ∼1 week after all requested materials are provided. As part of our consulting assessment service we catch and identify suspect issues in your study early, before they grow too big to manage or resolve.
A Health Check evaluates:
- Study design issues, potential data quality problems
- Long term impact and root causes of under-enrollment
- Projected budget overruns, logistics failures
- Projected timeline delays, missed milestones
Summary of a Study Assesment
The Study Health Check is a trial overview that identifies issues that may indicate your trial is in jeopardy. Our team of rescue experts will examine your enrollment, site activation, regulatory status, vendor and data status, and budget. After a thorough review, we will provide you with an easy-to-read report that can be used to shore up problem areas internally or accelerate the need for additional intervention. Schedule a call with one of our experts Today!
It’s not enough to say “Your study is/isn’t faltering.” We take the time to identify findings, insights, and overall study results specific to your trial that will give you the best picture of trial condition and best options moving forward.
Most clinical trials have some areas of concern at any given point, and some have multiple issues at once. Biorasi’s Study Health Assessment will identify current as well prioritize future issues, and identifying what needs to be addressed first.
Not all clinical issues are equal, and no two studies are the same. How do you know if your study is at risk or on budget and on schedule? Biorasi leverages our rescue expertise developing an objective study snapshot,.
Our Rescue consultants use your data to plot your planned timeline against an extrapolation of the current state of your study. Our independent analysis gives you the tools to objectively assess your current plan.
Frequently Asked Questions
More importantly, a Study Checkup can often find evidence of emerging issues that have the possibility of turning into much larger problems down the line, giving you ample time to take corrective measures without requiring an extensive and expensive intervention.
We understand that sponsors might not want a large commitment of time and information for a free consulting report, so we’ve structured the information we collect to provide the maximum insight with the minimum amount of required details from the sponsor. All information submitted is covered under a strict NDA, and remains completely confidential. Since this is a free product, the report itself is an overview, rather than a deep dive into the inner workings of any given study. It provides a high-level look at whether you can benefit from a trial rescue or not, and is not meant to be a definitive plan of action. Our goal is to balance accuracy against speed and commitment to come up with something that will be genuinely useful for sponsors, without requiring a full-scale consulting project.