Tag: CNS

Advances in non-opioid options for post-operative pain management

Advances in Non-Opioid Options for Post-Operative Pain Management

In a statement last August, departing FDA Commissioner Scott Gottlieb outlined several steps the agency had planned to further address the opioid crisis. Part of that approach, he wrote, includes supporting development of non-opioid, non-addictive alternatives for acute and chronic pain. The FDA plans to outline a path for developing …

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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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Traial Planning Save ALBP Trial some Pain

Biorasi Rescue Effort Doubles CNS Trial Enrollment Rate Leveraging experience to predict problems before they affect clinical trial deliverables Download Case Study The Challenge:Not every study presents a completely new and unique set of challenges. That’s not to say that the trial is generic, or not complex, but rather that …

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Biorasi’s TALOS™ Platform and Unique Sites Win Unusual ANDA Trial

Biorasi’s TALOS™ Platform and Unique Site Win Unusual ANDA Trial Flexibility and Strong Process-driven Planning Overcomes Regulatory Speedbumps Download Case Study The Background:ANDA approval for therapies going off-patent are typically a staid affair. Timelines are established years in advance, procedures are standardized and well-tested, sites and patients are largely uniform …

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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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