Ten Years of Academic Writing

Preparing for a Clinical Trial

Preparing for a Clinical Trial

Vincent Triola

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

Preparing for a Clinical Trial

Vincent Triola

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

ICH Guidelines & FDA Regulations: Design of Clinical Protocols

ICH Guidelines & FDA Regulations: Design of Cli...

Vincent Triola

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

ICH Guidelines & FDA Regulations: Design of Cli...

Vincent Triola

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

Risk & Benefits in Clinical Trials

Risk & Benefits in Clinical Trials

Vincent Triola

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.

Risk & Benefits in Clinical Trials

Vincent Triola

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.

The Role Played by The Clinical Investigator

The Role Played by The Clinical Investigator

Vincent Triola

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 Role Played by The Clinical Investigator

Vincent Triola

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.

What is Price Gouging?

What is Pharmaceutical Price Gouging?

Vincent Triola

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...

What is Pharmaceutical Price Gouging?

Vincent Triola

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...

GCP-Related Laws, Guidance, & Standard Operating Procedures

GCP-Related Laws, Guidance, & Standard Operatin...

Vincent Triola

The need for GCP to be linked with SOP, regulations, and guidance has been long recognized. Since the 1970s GCP has become a dominate link between clinical research practices and...

GCP-Related Laws, Guidance, & Standard Operatin...

Vincent Triola

The need for GCP to be linked with SOP, regulations, and guidance has been long recognized. Since the 1970s GCP has become a dominate link between clinical research practices and...