Defining What Is Off-Shoring And Its Important During Clinical Trials (Coursework Sample)

Offshoring
Student name
Institution Affiliation
Instructor name
Course title
Due date
Off-shoring
A good clinical practice is an international ethical which is scientific quality standard for the design, performance, conduct, monitoring, recording, auditing, reporting and analyzing of clinical trials. In our study will put consideration in the Europe as the country where ICH-GCP is practiced. This is because Europe is known globally as the part where good clinical activities take place and also it is where the clinical trials started, and for that reason, it is highly developed just as the United States is.
Off-shoring in Europe has led to a reduction of the cost of clinical trials. It is so cheap to attain clinical trials in Europe due to reduced cost (Antràs, Garicano, & Rossi-Hansberg, 2006). Secondly, it has protected the rights, confidentiality and the integrity of the trial subject in Europe. The subjects are taken care of, and their rights are observed strictly to ensure that their health is taken care of. It has also led to reduced length in the on each trial. Not forgetting the licensing ability created by the offshoring in Europe to market the new drugs in all parts of Europe which have created a lot of benefit to the pharmaceutical companies in marketing their drugs.
On the other hand, the risk of violation of trials has also been a major problem in offshoring clinical trials in Europe (Blinder, 2006). Secondly ability to monitor the offshoring has been so down in Europe despite been one of the major centre of ICH-GCP. The monitoring has been a big issue, and it needs to be addressed.
Europe is highly involved in the matter of e...