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
  • Under-enrollment
  • Budget overruns
  • Logistics failures
  • Timeline delays
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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
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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!

1. Key Findings
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.

2. Study Concern Priorities
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.

3. Overall Study Health
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,.

4. Enrollment Projections
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

No, any trial can benefit from an early review by a third-party. Even if your trial is on track, on budget and appears to be completely healthy, a Study Checkup might be able to help you identify opportunities for optimization and improvement. If nothing else, it will give peace of mind to your executives, investors, and other stakeholders.

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.

A typical Study Checkup takes approximately one week to complete, from the time we get all the information we need to the time you have a report in your hands. When designing our study checkup process, we wanted to find an optimal balance between timeliness and depth. A week gives us enough time to accurately and thoroughly review your information and to identify specific, actionable information.
The Study Checkup is an overview of the overall health of your trial, and answers the question: “Is my study on track to hit our program goals?” To answer that question, we’ll review the information you provide in the Study Checkup Questionnaire. This includes such information as your study protocol, start date, site status information, enrollment numbers and enrollment venue strategy, data entry and SDV metrics, and the overall timeline you provide us. We’ll use this information to forecast the likelihood of your trial completing on schedule, and pinpoint some red flags that may indicate your trial is in danger of missing milestones and targets. If your trial appears healthy, we will let you know and also provide suggestions that may be used to increase the efficiency of your trial. These optimization insights are geared towards helping you complete your trial ahead of schedule and on budget. If we find that the trial may be at risk, we will provide information on factors that may cause time, budget, or quality threshold overruns. We will also provide suggestions on whether the risks may justify a study intervention, based on the information available to us. Occasionally, we will encounter a study that is past the point where an intervention can realistically prevent the trial from failing to meeting its objectives. In those cases, we will be as straightforward as possible in presenting you with some potential options to mitigate the currently expected outcome.

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.

Our Program Management team would be happy to review your final report with you and go over any of the findings. If you would like to get more detailed and have us take a more in-depth look at your ongoing study, we also offer follow-up consulting projects that require more commitment and information, take more time, but in turn provide more detailed information on the specifics of your study, as well as providing a concrete trial rescue or intervention plan tailored to the specifics of your trial. If you would like to skip over the free Study Checkup and move straight to the deep-dive assessment, just let us know!

Excellent results require planning

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