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Keeping an Arrhythmia Trial in Perfect Rhythm

Monitoring 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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Illuminating the Diagnosis of Intracranial Hematoma

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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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In July 2008, FDA released a draft guidance to answer frequent questions about Form FDA-1572, also called the Statement of…
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Clinical Trial Accrual Hampered by Many Factors

In recent years, cancer patients are more knowledgeable and willing to participate in clinical trials, but issues pertaining to physician…
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Clinical Research Regulation: FDA vs. ICH

On May 9th, 1997, the US Food and Drug Administration (FDA) published in the FEDERAL REGISTER (vol. 62, No 90),…
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The Historical Rise of Pharmaceutical Regulation

The first rumblings for US drug legislation began after the Civil War, which had spurred the separation of drug manufacturers…
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Time Management for the Research Professional

It's been said that a pharmaceutical company loses $1 million for every day of delay during clinical research and development.…
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Latin Abbreviations Ad Nauseam

In case your Latin is a little rusty, here's a list of abbreviations commonly used in medical charts and prescriptions.…
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Surviving an FDA Inspection of Your Clinical Trial Site

The Investigational New Drug (IND) regulations went into effect in 1963. Ever since, the U.S. Food and Drug Administration (FDA)…
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Consulting is an Art

...or Why I'm Not a Singing CRA. During those confusing and wondrous years, when a young man ponders his career…
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Illuminating the Diagnosis of Intracranial Hematoma

Without urgent pressure-relieving surgery, the chance of survival drops quickly for head trauma patients having a severe intracerebral hematoma (bleeding…
Read More
FDA’s Bioresearch Monitoring (BIMO) Inspections

BIMO, the Bioresearch Monitoring Program, is a Food and Drug Administration (FDA) program of on-site inspections to ensure the quality…
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