In the Spanish pharmaceutical and medical service sector, it has become increasingly popular to work with companies specialized inclinical trialsthat offer their services as CROs(Contract Research Organizations).
At the 11th Congress held by the Medical Association of the Pharmaceutical Industry (AMIFE, as per the Spanish acronym), held on November 12-14 in Madrid, one of the issues discussed was the status of the Clinical Trial Royal Decree, which is currently awaiting the ruling of the State Council, since the text is almost finished, as stated by Mr. César Hernández, Head of the Committee on Medicinal Products for Human Use of the Spanish Agency of Medicinal Products and Medical Devices (AEMPS).
Clinical trials are complex, because pharmaceutical and biotechnological companies follow the strictest testing for what is the fruit of their time, resources, talents and creativity, always in compliance with applicable national and international policies and regulations.
ThePediatric Regulationpassed in 2006 established a system of obligations, rewards and incentives to ensure that medications for children are researched, developed and authorized based on the needs of the pediatric population.
In the field of clinical research, perhaps one of the areas that has most clearly evolved over the years is data management, particularly with respect to the methods of data collection and database creation and preparation for subsequent analysis while ensuring their integrity and quality at all times.