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Clinical Trials in Healthcare Training

American Medical Compliance

Before beginning a clinical trial, drug developers must design their study based on the goals of each research phase and submit an Investigational New Drug (IND) application to the FDA. The pharmaceutical industry relies on electronically captured data for drug evaluation, necessitating strict adherence to good data management practices.

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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

The selections feature topics ranging from how Wikipedia pages communicate drug efficacy information, to addressing pharmaceutical industry payments to physicians, to the frequency with which the Food and Drug Administration removes hazardous dietary supplements from the market. 2022 Jul 19:S0895-4356(22)00182-2.

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How the Life Sciences Industry Can Boost Diversity and Inclusion Efforts

HIT Consultant

The FDA is attempting to address this, having issued guidelines related to diversity in clinical trials in November 2020 – perhaps prompted by widespread media coverage of the fact that the black members of the society and other people of color were underrepresented in clinical trials for COVID-19 vaccines.

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3 Lessons Learned from Pandemic-Era Clinical Development Regulatory Practices

HIT Consultant

The pandemic has given rise to new norms in drug development that will influence the future of the industry as we know it. The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools. Here’s a look at what we’ve learned from COVID-19 era regulatory practices in clinical development.

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Overcoming Key Hurdles in Decentralized Trials with Better Education

HIT Consultant

As with countless global industries, clinical trials were forced to move key functions online as COVID-19 swept the world in early 2020. Further underscoring this trend, 93% of sites also reported that they would allow sponsors or CROs to conduct remote monitoring, compared to 74% pre-COVID. About Robert Geckeler.

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Future Trends and Regulatory Challenges in Pharma

Dot Compliance

The global pharmaceutical industry has seen its share of challenges in recent years, from manufacturing and supply chain bottlenecks to growing demand for faster delivery of drugs to the marketplace. The next evolution is for companies to implement Industry 4.0 What will the near future bring to the table? References.

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SQA Regulatory Surveillance Summary for January and February 2024

SQA

9 Lessons Learned from the COVID-19 Pandemic, January 2024 As a result of the COVID-19 pandemic, many industries (the pharmaceutical included) went through a substantial disruption. 9 Lessons Learned from the COVID-19 Pandemic provides lessons learned from pharmaceutical manufacturing.

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