What Is A Full Service Clinical Research Organization?
When an organization is trying to study the biochemistry of a material, bring a drug to market or test a new device, it has to observe a rigorous process to verify that the product is safe and effective. To accomplish this goal, the manufacturers may turn to a clinical research organization. This is a firm that's built specifically to put together, manage and analyze trials. If you're wondering what they can do for you, consider the following four items.
One of the first problems to address is how to design a test that will meet the standards set forth by your company, the government and your industry. Medical test design is a process that requires know-how regarding biology, group organization and statistics. Due to the increasing role of analytics and machine learning in the industry, it's normal for a full-service clinical research organization to also bring serious computing power to bear on projects too.
The question of doing work in-house versus outsourcing is also a big one. Most companies have the resources to do laboratory work on their own, but other aspects of the process are frequently outsourced. This may extend to things like recruiting volunteers, conducting trials and assembling data. Mixed in-house and outsourced solutions may also be employed, especially on very large projects.
Keeping Up with Regulations
The regulatory framework that surrounds modern medical testing is massive and ever-changing. New rules are implemented every month, and keeping up with them can be a challenge. Working with a clinical research organization means dealing with a firm that places a priority on knowing the new regulations and keeping your trials in compliance with them. The same goes for keeping up with shifts in cultural norms and industry standards. This can save significant money because no one wants to toss out the results of a trial due to it not meeting guidelines.
Even the most ethical company on the planet can struggle to keep the push to finish a project from spilling over into different divisions. A major advantage of hiring a full-service clinical research organization is that it creates a partition between your company's pressures and the trial process. This ensures that biases are less likely to be imputed into the process, reducing the risk of ethical breaches and perverse incentives. The end result is a clean and efficient trial that produces solid science.