Standard Operating Procedures (SOPs) have long been fundamental to many industries, and the clinical trials sector is no exception. Yet, too often, after companies devote significant time and resources into creating SOPs, they may not be followed. They may be ignored or even avoided. Failure to keep accurate records and establish and maintain SOPs appear frequently in Form 483 violations and Warning Letters issued by the FDA.
With the advent of intelligent document routing technology, stakeholders have the ability to support country-specific document regulatory workflows. This functionality allows for better compliance with SOPs, which, in conjunction with regulatory pressures, help boost operation efficiencies of clinical trials and shorten cycle times in the study startup phase.