Clinical Research Organizations: Things To Consider Before Hiring Them

By Author: ken smith
Total Articles: 10
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It is a growing trend among pharmaceutical companies to outsource their clinical trials to specialized agencies called clinical or contract research organizations (CROs) in order to accelerate the drug development process. Go through this article that highlights some of the key factors a pharma (or sponsor) should consider before hiring a clinical research organisation.

Strategic Reasons to Outsource

It is essential that a sponsor pays maximum attention to strategic reasons to ascertain that they are optimizing the association and making the most of their relationship with a CRO. Effective planning of the trials is imperative with the four major conditions being the trial quality, flexibility, reporting technique and speed. A pharma that focuses on these conditions boosts its probability of success. Pharmaceutical companies should also comprehend that trial planning is vital to sustaining a uniform degree of control which they would have attained if they were carrying out the tests within their own facilities.

One of the primary reasons that drug companies opt for outsourcing their trials is the ...
... decrease in fixed costs. Furthermore, it will probably be more cost-effective to hire a contract research organization that already has sophisticated technology in place, instead of attempting and executing this technology within their business. The same is applicable to professional know-how. Utilizing qualified and experienced manpower in a different facility can be more affordable than imparting the requisite training to their own staff.

Outsourcing internationally to contract research organizations brings into play issues like quality of data, cultural significances, communication procedures, statutory regulations and legalities.

Labor Expenses

Labor expenditure is the key factor behind outsourcing since it generally constitutes about 80 percent of the entire trial cost. Though the global labor cost is considerably cheaper in up-and-coming markets, the turnover of workforce at global facilities might be substantially higher. This is because of the speedy growth in the number of research labs. As soon as novel facilities come into being, competent members of the workforce are recruited from other existing clinical research organizations. The sponsor must analyze the training records of any potential partner and select an organization that boasts well qualified manpower working at the facility for a prolonged period of time.

Legal Issues

It is a common thing for any pharma to be very careful about the violation of intellectual property. Likewise, it is anticipated that any clinical research organisation will be vigilant against any harm caused to its repute because of allegations of embezzled information. Global labs can adopt notably different approaches towards insurance coverage and conflict resolution. In the wake of these factors, it is essential that all the clauses in a contract have been completely evaluated and understood before signing any agreement. Everything needs to be transparent. For instance, what will be the course of action if a pharma disapproves trial outcomes and claims the repayment of its money? Laws and regulations vary from one country to another and pharmaceutical companies may think about engaging a local solicitor to give advice to them on any contractual agreements.

Communication

This factor is crucial to the successful association between a drug company and a contract research organization since different nations have different styles of communication based on their culture. In Western culture, faults and errors are frequently revealed fast and their exposure is normally advocated. However, for several clinical research organizations, this acknowledgement of the fault might be regarded as a disgraceful act. It is vital that a trial plan has been carefully approved by both parties and their expectations are determined and free of ambiguity.

So, these are some of the factors that a pharmaceutical company should look at before getting associated with a clinical research organisation.

Ken Smith is an experienced clinical research coordinator and emphasizes the importance of contract research organizations in pharmaceutical and biotechnology industries. Visit his website to learn how to hire the best Clinical research organizations for conducting your medical trials.