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It is essential for pharmaceutical companies to choose an appropriate contract research organization for clinical trials.
FREMONT, CA: Outsourcing to Contract Research Organizations (CROs) is an integral part of producing medicines for the pharmaceutical industry. The overall level of outsourcing is expected to rise for both large pharmaceuticals and smaller biotechs, which partner with CROs for clinical trials.
Many CROs offer funding for medicines and medical devices for clinical research and clinical testing. It provides its customers with the experience and means of bringing a new drug or device from its creation to FDA or EMA marketing approval, without the drug's sponsor having to retain staff for these functions. According to Wikipedia, there are over 1,100 CROs in the country, some with annual sales of up to $ 4.3 billion.
Choosing the best CRO to handle a clinical trial may be a crucial decision for the program's successful outcome. Selecting a CRO is no different in certain respects than choosing any other supplier. However, there are also unique complexities in the relationship between a sponsor and a CRO. Here are some of the ways that can help to evaluate CROs.
1 EXPERIENCE & SERVICE PORTFOLIO
It's necessary to consider the company's experience when assessing CROs, but most importantly, their expertise in the therapeutic field. Get a sense of their track record and whether they have delivered to their customers regularly. Ask about the particular kinds of trials on which they have been working. The various stages of drug development require different sets of skills. Trials in Phase I can be very fast, while Phase III can be very challenging.
2 FINANCIAL STABILITY
By their very nature, CROs operate with considerable business risk because their job includes designing goods that might not eventually be accepted and commercialized. For various reasons, clinical trials may be canceled at any moment, so it's crucial to ensure that the CRO the company chooses has ample financial bandwidth to handle the industry's challenges without having a detrimental effect on the project. In order to minimize unexpected issues, question how long the CRO has been in operation, and determine if their project portfolio is adequately diversified.
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