How are Patients Protected During Clinical Trials?


1st January, 1970

How are Patients Protected During Clinical Trials?

Amid the latest regulations for drug testing, the pharmaceutical industry continues to work on the best solutions to protect the patients involved in clinical trials. In order to understand how, it’s best to find out what those laws indicate and the methods to benefit both the pharmaceutical companies and their patients.  

In the past two decades, the best approach for pharmaceutical companies to test their medicine has been by outsourcing their activities to contract research organizations (CRO). These businesses provide the capacity to run clinical trials, as well as help implement commercialization, biopharmaceutical development and more. In the perspective of pharmaceutical corporations, CROs have reduced the need for ‘in house’ activity by providing a cheaper channel for companies to attempt new medicines, and a cost-effective solution to cultivate drugs for niche markets. CRO’s have also created benefits by supplying external support and expertise.

Food and Drug Administration

In order for clinical trials in the U.S. to be approved, they must have marketing approval from the Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety of human and veterinary drugs, as well as biological products, and medical devices. They are in charge of aiding the public health by helping accelerate innovations that make medicinal products more effective, safe, and more affordable. They are also in charge of guaranteeing the public get the accurate information they need to use medicinal products. FDA’s bioresearch monitoring (BIMO) regulation handles on-site inspections of both clinical and nonclinical studies performed, in which CROs must adhere to these policies.

Medical Device Regulation

Clinical trials must also conform to the Medical Device Regulation (MDR). The MDR is responsible for the high standards of quality and safety of medical devices being produced in or supplied to Europe. Although the regulation took effect last year, a transition period has been in place and lasts until the 26th of May 2020 when the procedure becomes binding across the EU. For the next two years, devices can be placed on the market under the previous EU Directive, and manufacturers, as well as suppliers, need to meet those conditions.

Would you like to find out more about how patients are protected during clinical trials? This September, the Outsourcing in Clinical Trials[HK1]  Southern California 2018 conference will provide an opportunity for you to learn about these businesses, their challenges and strategic developments in this industry. In this day and age, it’s crucial pharmaceutical companies are informed about how they can benefit from these businesses. For more information, please visit http://www.arena-international.com/octsocal/ or alternatively email us at: events@arena-international.com


 

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