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Keeping an Arrhythmia Trial in Perfect Rhythm

An Emissary Clinical Trial Success Story

clinical research in rhythmMonitoring a clinical research study requires more than comparing case report forms against medical records. The fate of an entire clinical trial may rest upon a clinical research associate’s less apparent skills. The diligence, professionalism and exceptional communication skills of an experienced clinical research associate may be needed to salvage a critical situation. This was one such situation where the clinical trial sponsor wisely insisted on an Emissary clinical research associate to monitor an important clinical trial.

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Saving a Struggling Safety Study

An Emissary Clinical Trial Success Story

rose-colored clinical safety glassesSelecting a contract research organization (CRO) from among the 1,000 or so competitors is a challenging task for any sponsoring pharmaceutical or medical device company. But, it is particularly difficult for an inexperienced team at a startup just entering Phase 1 human trials with their first new product. Such young companies are often working under extreme deadlines imposed by shortsighted venture capitalists clamoring for a press release announcing the start of clinical testing to buoy the stock price.

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Illuminating the Diagnosis of Intracranial Hematoma

An Emissary Clinical Trial Success Story

Without urgent pressure-relieving surgery, the chance of survival drops quickly for head trauma patients having a severe intracerebral hematoma (bleeding inside the skull). Sadly, the condition is too often not diagnosed in time. A technology with the potential to change that might have languished in the halls of academia if not for the dedication of a creative entrepreneur and an experienced contract research organization (CRO) committed to advancing lifesaving solutions for unmet medical needs.

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Recent Articles

FDA Form 1572 - Guidance on the FDA's Statement of Investigator Form

In July 2008, FDA released a draft guidance to answer frequent questions about Form...

Illuminating the Diagnosis of Intracranial Hematoma

Without urgent pressure-relieving surgery, the chance of survival drops quickly for head trauma patients...

FDA’s Bioresearch Monitoring (BIMO) Inspections

BIMO, the Bioresearch Monitoring Program, is a Food and Drug Administration (FDA) program of on-site...

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