Oct/Nov/Dec 2022

Volume 23, Issue 4

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Articles in this Issue

Adapting Skills to the New Data-Centric Regulatory Environment

As a data-centric approach becomes the new regulatory reality, product information managers and Regulatory teams need to consider as a matter of urgency whether or not their skills need to be ... read more
Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process...

The past decade has seen the pharmaceutical sector move away from small chemical molecules towards biotech products and personalized therapies. As companies scale up from lab-based scientific research... read more
Best Practices for Data Collection in Decentralized Clinical Trials

Over the past few years, impactful technology advancements have been made in the clinical trial industry that have resulted in better opportunities to conduct decentralized clinical trials (DCT). ... read more
Five Ways to Reduce Clinical Trial Costs from Bench to Bedside

A 2020 study reported the median cost to develop an on-market drug in the US was approximately $1.1 billion, reflecting a range between $314 million and $2.8 billion. Only 9.6% of new molecular ... read more
Tracking the Pharmaceutical Cold Chain: Why remote, reliable temperature monitoring through...

The arrival of fall is a favorite time of year for many of us, as trees across parts of the country burst with brilliant colors, and cool, crisp temperatures settle in. This often-calm season may seem... read more
Realizing the Potential of RWE with the Right CRO

Over the past few years, the number of regulatory submissions that include real-world evidence (RWE) - insights derived from data collected outside of traditional clinical trials - has increased by ... read more
Data Exchange Supersedes Structured Document Authoring

As regulatory and business processes are increasingly data-first, structured document authoring is facing obsolescence. Next-level structured content authoring places the emphasis on ‘data objects', ... read more
The Role of Artificial Intelligence in Drug Discovery

Despite the buzz around artificial intelligence (AI), most industry insiders know that the use of machine learning (ML) in drug discovery is nothing new. For more than a decade, researchers have used ... read more
Why It Pays to Invest in the Patient Experience

The pharmaceutical industry's understanding of the role of patients in clinical trials is evolving. Patients have always been at the center of clinical trials, but this has not always been reflected ... read more
How to Get Researchers to Adopt Electronic Lab Notebooks (ELNs) – Five Key Strategies for Success

The replacement of paper notebooks with electronic lab notebooks (ELNs) has become inevitable. Technology gurus have predicted this imminent shift since the early 90s. With the advent of lab ... read more
The Value of Predictive Analytical Applications as Digital Health Tools

The pace of wearable sensor device deployment in decentralized clinical trials is increasing significantly. These devices capture enormous amounts of data from patients in real-world settings, ... read more
How Digitalization and DCTs are Transforming the Clinical Landscape

COVID-19 shifted sentiment toward decentralized clinical trials and demonstrated that they could benefit patients and sponsors alike. Dr. Rajesh Jain of PharmaLex discusses changing sentiment and the ... read more
Transforming RIM – Connecting the Enterprise, the Patient and the Market to More Timely...

Most major life science companies have spent the past decade modernizing their regulatory information management (RIM) platforms. Now, strategies are evolving to build on this foundation, streamlining... read more
How to Improve Diversity in Clinical Trials: Achieving an Industry Imperative

Improving diversity in clinical trials is an industry imperative for achieving health equity. In an analysis reviewing participation of racial and ethnic populations at US sites between 2015 and 2019,... read more
A Quarterly Review of New Drug Applications – July-September 2022

This quarterly review on New Drug Applications (NDAs) contains data for applications approved for the first time during the third quarter of 2022, which includes New Molecular Entities (NMEs) and new ... read more
Editor's Message: Stressing Out Over Wearable Tech

Have you heard of the “white coat effect”? I’m sure most have, but for those that have not, here’s a quick definition. Basically, the white coat effect occurs when your blood pressure is measured in a... read more