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What are clinical trials and why do they matter?

Clinical Research Organisations (CRO)

As you can imagine a medical trial takes a lot of organising. Apart from the encyclopedic set of rules that must be obeyed, someone must keep track of all the volunteers, make sure they follow the rules of the drug trial, make sure any side-effects, recoveries and changes in symptoms are properly monitored. That is where Clinical Research Organisations come in.

When it comes to clinical trials, they do the hard work for pharmaceutical companies. They recruit the volunteers, make sure they qualify, manage the medical trial, do the safety monitoring, manage the data, all the biostatistics and prepare the FDA New Drug Application paperwork.

The CRO industry really emerged in the 1990s as pharmaceutical companies became more competitive and more and more potentially lucrative drugs were discovered.  It became cheaper for pharmaceutical companies to outsource their clinical trials. Today, however, CROs play a very influential role in the pharmaceutical industry as their work is crucial to the success of new drugs.

Globally it is estimated by analysts that outsourcing contracts to CROs are valued at $20 billion.

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