Rescue Your clinical Trial Before It's Too Late.
"40% of trials are at risk"
The biggest issues for faltering trials? Incomplete planning and enrollment issues can explode into big problems if not addressed early enough. Biorasi offers a no-commitment, no-charge, fast consulting assessment that will identify and correct these issues in your study early – before they grow too big to manage.
Starting with a study health assessment, Biorasi reviews trial milestones, processes, progress, gap analysis and prepares a full report highlighting risk mitigation methods and best practices for ensuring a successful study completion.
Understanding the condition of the study and its probability of a successful completion will illuminate options that will dramatically improve your outcome, saving you money and time.
IS YOUR TRIAL IN DANGER?
More than 40% of all clinical trials currently running for FDA or EMA approval are in danger of missing deadlines or already missed key deadlines and milestones. These clinical studies experience problems for a wide variety of reasons.
We have Experts available to answer your questions
Biorasi 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. Complete the form below to speak with our team of experts.
Most trials can be rescued if key indicators are closely monitored 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. If needed, Biorasi can work both as an integrated CRO, as well as a transition CRO, to allow us to customize our trial rescue solution to best meet the needs of your study
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 Assessment
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.
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.
Biorasi ran a study checkup, and let me know that there was no way to get everything done in the time we had. It was bad news, but it cost me nothing, and I had an answer in days. It’s refreshing to see an organization in this space that is this honest and upfront, even when delivering bad news."
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.
What Our Are Saying
Don’t just take it from us, let our sponsors do the talking!
The study checkup is a fantastic tool, and it’s surprising that other CROs are not talking about early study reviews to make sure things are going on track."
They [Biorasi] fixed our recruitment issues quickly, and found other serious issues that would have likely compromised the entire program.
Suffice it to say, we’re sending all future work to Biorasi."