40% Of Clinical Trials Are At Risk
Is Your Trial In Danger?
The biggest culprit for faltering trials? Incomplete planning can snowball into big problems if not addressed early enough. The Biorasi Study Checkup is a no-commitment, no-charge, and fast consulting assessment that can catch and correct these issues in your study early – before they grow too big to manage. Our Study Checkup will help you uncover:
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
Contact us to receive a study checkup from Biorasi.
It’s FAST. It’s FREE. It SAVES trials.
Our Study Checkup Process
Identify Red Flags
Evaluate Trial Success
The Anatomy of a Study Checkup
The Study Health Checkup is an overview of your trial that identifies red flags that may indicate your trial is in trouble. Our team of industry 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 submitted to a manager or board to help you explain the need for an external 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 what’s happening and what your best options are moving forward. If your trial is at risk of faltering, these will be red flags and potential issues. If your trial is healthy, we’ll use this space to give you ideas on study optimization.
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 Checkup is a full 360 degree look that can spot and highlight current and potential problems. Then, we use our extensive experience as a rescue CRO to prioritize these issues, so you know exactly what needs to be addressed first.
3. Overall Study Health
Not all clinical issues are equal, and no two studies are the same. How can our sponsors know if their study is at risk or if they’re still on budget and on schedule? Biorasi leveraged our knowledge as an industry-leading trial rescue CRO to put together an objective study snapshot, that gives you an at-a-glance view of how likely your trial is to miss key deadlines and milestones.
4. Enrollment Projections
Our Program Management consultants use the data you provide to plot your planned timeline against an extrapolation of what is actually happening with your study. If you are skeptical of the projections you are currently receiving, our independent analysis will give you the tools you need to challenge your existing plan, which could be misguiding your study.
What Our Sponsors 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. ” Small CNS Company
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. ” Mid-Size Specialty Pharma
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. ”
Large Biosimilar Company
Frequently Asked Questions
Is the Study Checkup only for trials that are failing?
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.
How long does it take to get the results?
What kind of insights can I expect from the Study Checkup?
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.
How much information will I need to provide and how detailed is the Study Checkup report?
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.
Is there a way I can follow up on any of the insights in the report, or get additional details on any of the points?
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!