BackgroundCell and gene therapies (CGT), often referred to as advanced therapeutic medicinal products (ATMPs), are rapidly emerging as favorable treatments, repeatedly targeting rare, ultra‑rare diseases and fall under regulators’ expedited programs [1]. To date, the...

Data provenance in Real World Evidence (RWE) studies has quickly becoming an increasing focus in the industry, especially as 90% of pharmaceutical companies today have Real World Evidence teams according to Deloitte. If an audit is underway, for instance, consider an...

From a drug development perspective, benefit-risk assessments can sometimes feel abstract. However, from a patient's perspective, they are a lived experience with a disease state and therapy. One benefit-risk assessment exists in paper and data, while the other lives...

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...