Regulatory Compliance Archives - Medical Design Sourcing

Navigating the intersection of technology and human expertise in life sciences

[Adobe]

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 in areas such as meeting regulatory requirements, managing data availability/ date volume/ data congruence and, in some cases, ensuring commercial viability. These limitations must be addressed for successful adoption across the healthcare industry and for implementation of such tools into broad based quality management systems and product solutions.

True success hinges on the effective implementation and strategic utilization of technology, guided by human expertise and supported by well-designe…

Unifying disparate data in clinical trial management with advanced data technology

[Image courtesy of Adobe Stock]

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 data across clinical trials.

Organizations are now faced with the need to centralize data and are increasingly adopting advanced data and analytics capabilities to bring efficiency to data centralization and democratization processes.

Regulatory challenges, incongruous data and increasing stakeholders

As accountability shifts with regulatory guidelines, sponsors increasingly carry the burden of clinical trial oversight, taking responsibility for any unforeseen proble…

Navigating the new regulatory terrain pharma companies face with IRA and 340B

[Image courtesy of Adobe Stock]

The ever-evolving landscape of pharmaceutical regulations has long been challenging to navigate, but now pharma companies face additional complexities with the introduction of the Inflation Reduction Act (IRA) and the ongoing implementation of the 340B drug pricing program. In recent years, the IRA has made waves for its impact on the pharmaceutical industry, including proposals to allow Medicare to negotiate drug prices for the first time and imposing rebates on drug price increases that outpace inflation. Additionally, the 340B Drug Pricing Program, which was created in 1992, is a U.S. federal government program that aims to allow healthcare organizations to offer affordable prescription drugs to underserved and low-income populations. In 2021, 340B backed entities purchased $43.9 billion worth of covered outpatient drugs under the program.

To get a clearer sense of how the indu…

No room for error: How a holistic quality management strategy can help pharma firms adhere to strict quality standards

[Adobe Stock]

Ever heard the phrase “one bad apple spoils the barrel”? The proverb rings especially true in pharmaceutical manufacturing, where even trace amounts of contaminants can have grave consequences for patient safety. “In the case of pharma, the stakes are so high that even the tiniest contaminants can endanger patients and result in wasted therapeutics, amounting to millions of dollars,” says Dan UpDyke, life sciences strategic marketing manager at Rockwell Automation.

In the following interview, UpDyke explains how a holistic quality management strategy in pharma can help manufacturers adhere to the industry’s strict regulatory standards. Such an approach can help pharma companies avoid problems related to sub-standard ingredients, possible contamination, or a temperature excursion during delivery, all of which can jeopardize the integrity of the entire product.

In the following interview, UpD…

Bridging bioanalytical gaps: Examining validation methods across species

[Anela R/peopleimages.com/Adobe Stock]

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 differences requires an understanding of species-specific metabolic and physiologic characteristics. Therefore, customizing a validating method may involve modifying sampling procedures, adjusting analytical parameters, or incorporating species-specific biomarkers. Whether method developers and sponsors do this work in-house or call on a laboratory partner for help, successful validation is when the method consistently delivers accurate and precise results within th…

Driving pharma lab digitalization forward with LIMS

[Gorodenkoff/Adobe Stock]

The digitalization battle in pharmaceutical labs has heated up in recent years. Factors contributing to the trend include mounting pressures of rapid technological evolution, increasing regulatory requirements and a growing demand for efficiency and accuracy in all facets of laboratory operations. 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 control.

While LIMS is a game-changer for the pharma industry, with the potential to dramatically increase productivity, reduce errors and ensure compliance with regulatory standards, many labs are lagging in terms of LIMS adoption. The reasons for this are far ranging, including from financial constraints to fear of change and a lack of understanding about the benefits of…