What are the Challenges Related to Contract Research Organization
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What are the Challenges Related to Contract Research Organization

Stacey Smith, Pharma Tech Outlook | Wednesday, March 10, 2021

The pharmaceutical and medical device industries are using contract research organization, but it also has several challenges and maintain quality standards. 

FREMONT, CA: Contract research organizations (CROs) are outsourcing firms that provide contract research services to the pharmaceutical, biotechnology, and medical device industries. CROs are typically employed by pharmaceutical firms known as sponsors to conduct tasks such as drug discovery, production, and testing. CROs, like any other niche company, face their own set of challenges.

How Do Contract Research Organizations Work?

Top 10 CROs in APAC - 2020Contract Research Organizations provide clinical trials and other research support facilities to their sponsoring companies. They give money to medical organizations, government agencies, charities, and colleges. Many of these sponsors hire CROs to run their trials on their behalf, so they don't have to keep a team on hand for these short-term services.

Product development, clinical trials, laboratory facilities for processing trial samples, medical writing, regulatory affairs, post-marketing surveillance, and other complementary services are available through CROs. Sponsors use CROs to get their drug proposals approved and then send them to the FDA for premarket approval.

Challenges of Contract Research Organizations

High-Quality Standards

To be qualified to perform studies, CROs must meet several criteria. First and foremost, they must adhere to global standard operating procedures (SOPs) and conduct systems audits to ensure that all staff is following them. All trial workers should be qualified in Good Clinical Practice (GCP) and local laws and other guidelines.

According to GCP guidelines, the primary responsibility for the accuracy and fairness of the trial data still rests with the sponsor. CROs must, however, meet quality assurance and quality control standards because their credibility and customer loyalty are dependent on their ability to obtain regulatory approval for their products.

Loads of Paperwork

Sponsors and CROs usually agree on the terms of the study's execution. They specify which materials and methods will be used in the research and the type of data collected, and the tests that will be conducted. The agreement and study results are usually documented electronically and on paper,

The data from the analysis is collected, evaluated, and summarized until it is completed. Final reports are written in plain language and usually stored and circulated electronically or on paper. All this documentation requires adequate storage and management in libraries and online databases, entailing many human and physical resources, as well as a high degree of security and order.

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