Ten Years of Academic Writing

Preparing for a clinical trial begins in sponsorship and ethics applications. All clinical trials must have sponsors and meet ethical standards prior to commencements.

The FDA and the ICH both have similar requirements for designing clinical protocols. These protocols are outlined by the FDA’s regulatory environment.

The LOCHOL Study presents a number of risks and benefits. The study entails providing subjects with a 250 mg dosage of LOCHOL for two weeks.

Informed consent is both an ethical directive as well as a law. This understanding is vital carrying out a successful clinical trial because understanding informed consent provides the necessity for...

The role of the Investigator’s Brochure (IB) is to provide a complete summation concerning the information gathered during the investigation of a drug or medical device.

The U.S. Pharmaceutical industry is often accused of price gouging due to extreme cost of medications. The Pharmaceutical industry would argue prices are high when initially introduced to the market...