Computer system validation (CSV) is a core item that regularly comes up during regulatory inspections. And, the US Food & Drug Administration (FDA) conducted 2,442 inspections in 2022, according to a recent report. To ensure inspection readiness, a two-part series...
Good Laboratory Practice (GLP) is a quality control system for clinical research laboratories and organizations to ensure the integrity, consistency, and reproducibility of the data within non-clinical and clinical studies of products in development for human or...
Standard Operating Procedures (SOPs) in the pharmaceutical industry are documents used by an organization to provide step-by-step actions for a specific process. And, according to a published study in ResearchGate, a typical pharmaceutical company must manage an...
The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...
Quality in clinical trials is of utmost importance to the pharmaceutical industry, with the need for quality management systems estimated to grow to $4.5 billion by 2032 according to Global Market Insights. The best pharmaceutical pipelines are driven by good quality...
New Investigator Updates need to be made in the clinical study protocol and kept up to date to with the FDA. And, with more than 32,000 principal investigators globally, according to Applied Clinical Trials, these updates can occur more often than many clinical trial...
For veterans, trauma often persists even after their military service has ended; this trauma can overshadow a veteran's life, family, and future. Post-Traumatic Stress Disorder, or PTSD, is a result of carrying this trauma; PTSD is a debilitating condition that leads...
Plain language protocol synopsis (PLPS) is an important part in informing patients from the start of their clinical trial experience. On January 21, 2022, the European Medicines Agency (EMA) launched a new clinical trials website, Clinical Trials Information System...
It would be relatively easy if biopharmaceutical manufacturers could develop a perfect process one time and then rely on it to deliver the same high-quality products to all patients in all future scenarios; yet, changes in processes and sites are often necessary to...