Tag: Trial Rescue

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Shortening the pharmaceutical development lifecycle and reducing costs with IBM Clinical Development®

Shortening the pharmaceutical development lifecycle and reducing costs with IBM Clinical Development® Overview: Costs, overheard and time spent are factors Biorasi strives to reduce for its partners in complex clinical trials. IBM is the leading healthcare technology organization in the world. Recently, they wrote a case study on how Biorasi …

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Rescue Is Not A Dirty Word: 3 Measures to Overcome Operational Failures

‘Rescue’ Is Not A Dirty Word: Embracing Early Intervention in Faltering Clinical Trials Every year, tens of thousands of clinical trials are initiated. Every year, thousands of those trials falter, and, if corrective action isn’t taken, some may fail to produce usable data. In an analysis conducted by the Biorasi …

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Tactful Strategies Steer a Failing Trial to Safety

Tactful Strategies Steer a Failing Trial to Safety Overcoming More Than Just Language Barriers The Challenge: Global studies are notoriously complicated with language barriers, time zone differences, and oft-contradictory regulations. These business challenges are exacerbated, not only working with multiple, but unique cultures. Biorasi encountered this scenario when we were …

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A Patient-Centric Approach Rescues Complex TBI Study

A Patient-Centric Approach Rescues Complex TBI Study Improving Communication to Boost Patient Retention The Challenge: Site selection is one of the most crucial parts of planning a study. Ensuring that sites are performing up to par while a trial is underway is equally important but often neglected. Biorasi was asked …

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Teamwork: An Evidence-Based Approach for Trial Recruitment

Every clinical trial comes with its own unique challenges. Sometimes the biggest challenge faced by a trial is simply not enrolling enough participants. Well-documented reasons for challenges with recruitment can stem from a complicated or unrealistic protocol or poor communication between the sponsor and investigator. However, recent studies have shed …

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Not Enrolling Enough? How to Rescue Your Recruitment Strategy

A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. These delays are a big deal, since every day that is delayed can cost …

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Avoiding the Blame-Game in Rescue: Don’t Ask Who, Ask Why

Introduction Clinical trial rescues can often be a delicate topic for both sponsor and contract research organization. When a study goes off track, it’s natural to want to point fingers and look for who is to blame. However, performing a comprehensive root cause analysis and managing expectations and communication from …

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Strict Processes Rescue Complex MS Trial

Strict Processes Rescue Complex MS Trial Biorasi’s Project Management-first Approach Allows Rapid Feasibility and Site Startup to Meet Critical Deadlines The Challenge: A specialty pharmaceutical company engaged Biorasi to rescue their phase 2 clinical trial for treatment of spasticity caused by multiple sclerosis (MS). The incumbent CRO was not meeting …

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Quintessential Guide to Planning a Clinical Trial

The Quintessential Guide to Planning a Clinical Trial Clinical trials are complex undertakings, with complex planning required. Success or failure is often determined long before the trial even gets underway. Biorasi’s quintessential guide to clinical trial planning helps program managers and operations directors identify and resolve the sticking points that …

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Five Signs Your Clinical Trial Needs a Rescue

By some estimates, more than 90% of drug candidates never make it into consumer hands. That number shouldn’t come as a surprise to anyone who has spent time in pharma R&D, but thankfully most of those failed compounds fail early and relatively cheaply. What’s more surprising, though, is that a …

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Big Data can help minimize risk in clinical trials

Can Big Data Rescue Clinical Trials?

If you had to pick one buzzword that perfectly encapsulated the current latest and greatest in innovation, you could do a lot worse than “big data”. The last few years have seen big data and data mining introduced into nearly every field imaginable, often with disruptive results. Now, that same …

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Trial Rescue Effort Doubles CNS Trial Enrollment Rate

BIORASI RESCUE EFFORT DOUBLES CNS TRIAL ENROLLMENT RATE Patient Enrollment Needs To Be Strategic, Not Just Tactical Download Case Study Almost every company that has ever run a trial finds themselves, at some point, looking at enrollment figures and wondering if they’ll meet their patient and site quotas on schedule. …

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