Regulatory Compliance

In recent years, the clinical research landscape has been marked by a steady rise in protocol complexity with more endpoints and procedures across all trial phases and therapeutic areas. This trend, driven by the increasing sophistication of trial designs, is evident across trial phases and major therapeutic areas. Resulting in more endpoints and procedures on…

Pharmaceutical manufacturers are tasked with monitoring and reporting safety events (adverse events, product quality complaints, special situations, etc.) to protect patient safety. This process – detecting, documenting, evaluating, reporting, and following up – is essential to meeting regulatory standards and ensuring optimal patient outcomes. However, many of these critical events are not being captured today. …

Large molecule therapies hold immense promise for treating an array of diseases, but their development presents unique challenges in preclinical testing. Toxicology studies form a cornerstone of this process, providing essential data on the drug’s biological effects. While small molecule drugs have been the focus of drug development for decades, large molecule therapies present unique challenges…

The pharmaceutical industry has long faced something of a perfect storm of regulatory upheaval and technological disruption. But now is different. The Inflation Reduction Act represents a unique challenge for pharma companies as the U.S. government can force them to negotiate drug prices for some Medicare drugs. And despite its name, some pundits believe the…

While the pharmaceutical industry tries to remain competitive in today’s fast-paced digital world, chief information officers are left with a conundrum; How can they adopt necessary new technologies while dealing with existing technical debt? So what is this technical debt? When outdated processes or deferred maintenance accumulates over time which makes it hard for companies…

In this age of rapidly evolving technologies that fundamentally shift the way businesses operate, such as large language models (LLMs) and natural language processing (NLP), organizations are quickly realizing that success extends beyond innovative technology solutions alone. While these technologies offer immense potential in terms of innovation, data insights and operational efficiency gains, constraints exist…

The increasing complexities in clinical trials, including expanded patient populations, decentralized trials and new technologies, are directly impacting the amount of data and information available to clinical trial sponsors. Though this provides significant value to the industry, it presents a new challenge of consolidating disparate and siloed systems, improving standardization and unifying the explosion of…

Bioanalytical method validation is the backbone of effective drug discovery and development. Its pivotal role ensures the generation of reliable and reproducible data from diverse species, leading to safe and effective therapeutics. As critical as this process is, scientists face many challenges, particularly regarding validation across different species in preclinical and clinical studies. Accommodating species…

Digitalization has taken the pharma industry by storm. Most of the laboratories have embarked upon digitalization in the recent years. A central player in this transformative journey is the laboratory information management system (LIMS), a digital platform designed to manage all the data and processes in a lab, from sample tracking to reporting and quality…