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Who Needs to Comply With the Revised Common Rule and What Does It Mean for Informed Consent Forms?

Most requirements for the revised Common Rule are in effect. This article serves as a guide for researchers who are still unsure if they need to comply or what that means when it comes to informed consent form (ICF) requirements.

Content provided BY Marken: Global Life Science Supply Chain Solutions

Mastering clinical drug distribution in an era of advanced therapies and global trials

The composition of clinical trial pipelines is changing quickly as the rise of advanced therapies adds another layer to the multi-decade shift from small molecules to biologics. This change is fueling once-unimaginable advances in the treatment of cancers,...

Content provided BY Covance Inc

Mining Real-World Data with Cutting-Edge Analytical Tools

In 1848, the most famous Gold Rush in American history began at Sutter's Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous...

Content provided BY Marken: Global Life Science Supply Chain Solutions

How companies are realizing the potential of virtual and hybrid clinical trials

Virtual and hybrid clinical trials have arrived. Having learnt from pilot projects, pharma companies are systematically incorporating patient-centric services into trials, resulting in a significant minority of today’s studies featuring virtual elements....

Content provided BY PRA Health Sciences

Promise of progress: FDA commitment to enhancing pediatric medicines

The Commissioner of the FDA, Scott Gottlieb, recently informed a US House Committee on Appropriations of the agency’s intention to expand its guidance documents on developing drugs in specific disease areas to increase the number of new medicines in these...

Content provided BY R-Pharm Germany GmbH

New Track & Trace User Academy: Reducing the ramp up time by observing and learning T&T in the wild

Major markets are mandating the implementation of serialization. The new Track & Trace User Academy brings personnel up to speed on using equipment and processes correctly.

Content provided BY World Courier

Risk mitigation: mission critical

Pharmaceutical manufacturers need to understand and mitigate the risk in supply chain logistics. World Courier explore five rising trends impacting security of a product in transport.

Content provided BY World Courier

The move from cold-chain to temperature-controlled shipping

World Courier shares an overview of the key issues and new developments in temperature-controlled shipping.

Content provided BY RSSL

Extractables and leachables analysis of pharmaceutical products

A crucial undertaking when releasing pharmaceutical products for the market, is to determine the purity of the final product, necessitating the need to determine its impurity profile. Traditionally, this was concerned only with those impurities arising...

Content provided BY RSSL

Cleaning Validation - What do you need to consider to ensure a successful outcome?

Cross contamination must be avoided in the pharmaceutical industry at all costs. Successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must...