In America, the FDA (Food and Drug Administration) was established as a federal agency in 1906 with the Pure Food and Drug Act. Since then, they have protected the health of Americans by ensuring the safety and efficacy of medication, medical devices and biological products. 

Regarding clinical trials, the FDA evaluates the data on an investigational drug and decides whether it is safe enough to become available to the public. To do that, they need to be sure that the medication works and that the benefits outweigh any possible risks. 

Clinical Data Management (CDM) is an integral part of clinical trials and enables clinical trial staff to extract valuable, accurate, high-quality data during the clinical trial process. The final results of a clinical trial are only good if the data collected is reliable. Incorrect data can result in the wrong conclusions being made which can be a risk to participants and can tarnish the reputation of Contract Research Organisations (CROs) and clinical trial sponsors. 

Clinical Data Management (CDM) deals specifically with the information that is collected during the clinical trial. Its aims are to ensure quality, data, integrity and compliance with regulations and protocols. 

There are many clinical data management systems available and it can be difficult to select one to utilise. Comparing a few allows for an informed decision to be made. Look out for features like 

A Contract Research Organisation (CRO) provides research services to the biotechnology, pharmaceutical and medical device industries through a contract agreement. CROs have various functions and specialities. Ultimately, they operate as a hired agent that carries out specialised tasks for a trial sponsor. Any data that a CRO collects should be unbiased and meet the regulatory requirements which are then used in a participant-driven approach to drug discovery and device design. 

The Contract Research Organisation (CRO) industry is constantly changing and growing due to various key factors like a growing healthcare sector, research funds, a growing patient population worldwide and an increase in government support for research and development (R&D). According to the latest research, the global demand for Contract Research Organisation’s market size and share is expected to exceed around the US$65.5 billion mark by the year 2028.

Contact Research Organisations (CROs) have undergone many changes over the past few years, thanks to the COVID-19 pandemic and technological advances. There are even more changes for CROs in the future. One of the biggest changes will be how CROs respond to unforeseen emergencies, such as the unprecedented COVID-19 pandemic. As well as the ongoing advancement of technology and new medical treatments. 

The future of CROs includes: 

Technology Instead of Labour