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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

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,...

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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 Roquette Pharma Solutions

Introducing Roquette’s Pearlitol SW-F (wheat-free) DC mannitol for nutraceutical dosage forms

Providing on-the-go, health-conscious consumers with fast-acting, easy-to-take and affordable healthcare products is a top priority for OTC drug and nutraceutical manufacturers and marketers.

Content provided BY Marken

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 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 I Holland Limited - Tabletting Science

Collaborating with Lilly Spain to increase productivity through planned professional maintenance – Part 1

“The whole system will be very useful, it is very complete and more intuitive than any other system we have seen,.” – Pablo Poza, Maintenance Coordinator at Lilly Spain

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 Gattefossé

SEDDS for oral peptide delivery: Gattefossé insight

Peptide therapeutics are on the rise due to their high potency, specific mode of action and safety. Currently, more than 60 peptides are available on the market. About 140 are in clinical trials and 500 are in preclinical development (Fosgerau and Hoffmann,...

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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.

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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...

Content provided BY World Courier

Promotional Features

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

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

Mining Real-World Data with Cutting-Edge Analytical Tools

Introducing Roquette’s Pearlitol SW-F (wheat-free) DC mannitol for nutraceutical dosage forms

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

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

Collaborating with Lilly Spain to increase productivity through planned professional maintenance – Part 1

Risk mitigation: mission critical

SEDDS for oral peptide delivery: Gattefossé insight

The move from cold-chain to temperature-controlled shipping

Extractables and leachables analysis of pharmaceutical products

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

The logistics link in successful cell and gene therapy trials

Developing a new high throughput screen method to improve excipient selection for solubilisation

Risk in global logistics: the top overlooked factors

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