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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In July 2008, FDA released a draft guidance to answer frequent questions about Form FDA-1572, also called the Statement of
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
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),
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
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.
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.
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)
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
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
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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