Biorasi Trial Rescue Assessment Report

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


Sign Up to Receive a Study Checkup from Biorasi.
It’s FAST. It’s FREE. It SAVES trials. 

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Our Study Checkup Process

Review Study

Our experienced program managers review the study status for issues, oversights, and inefficiencies.
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Identify Red Flags

We identify potential issues and red flags before they put your trial in danger of missing milestones or blowing budget.

Evaluate Trial Success

Using our predictive trial model, we extrapolate your study path so you know where you will be if nothing changes.

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!

“Biorasi’s study checkup helped us identify some potential weak spots in our enrollment strategy that we had no idea existed. If we waited until it became a problem, it would have cost us more than I care to think about to fix. Since we found it early, we were able to address the underlying problems and the trial completed on time and on budget.

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

Chief Medical Officer

“We approached Biorasi to see if our clinical trial could be rescued. We were months behind our initial timeline and way over budget. We had a very narrow window that we had to finish our study in, and were nowhere close to being on track.

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

Director, Regulatory and Clinical Operations

“Biorasi came in to do a recruitment rescue for a pivotal study in our lead program. We were behind schedule and not getting any good answers from our incumbent CRO.

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

VP, Global Clinical Operations

Frequently Asked Questions

Is the Study Checkup only for trials that are failing?

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.

How long does it take to get the results?

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.

What kind of insights can I expect from the Study Checkup?

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.

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!

Still Have Questions?

If we didn’t answer all of your questions, feel free to drop us a line anytime. Our solutions team will be happy to explain our study checkup in greater detail!
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