Newsletter | February 5, 2020

02.05.20 -- ISR Projects Growth In eTMF Market


How many companies are actually making their trials more patient-centric? Join Clinical Leader Live on Wednesday, February 12, 2020, for a virtual conference examining what “patient-centricity” means from three perspectives: sponsors, patients, and advocacy groups.

Featured Editorial
ISR Projects Growth In eTMF Market
By Ed Miseta, chief editor, Clinical Leader

In December 2019, ISR Reports released the 2nd edition of its eTMF Market and Service Provider Dynamics report. The 118-page report collected data from 110 respondents who worked for sponsor companies and CROs and who had direct, recent experience with eTMF software systems.

Clinical Trial Root Cause Analysis: Can’t We Do Better Than Five Whys?
By Sandra “SAM” Sather and Keith Dorricott

Root cause analysis should be a chance to take a step back and try to understand why an issue occurred, and to think critically, understand the process, and determine how the issue came about. The “Five Whys” approach can lead us to a simple root cause and action, but does it enable us to really understand the issue?

Industry Insights
Expert Screen Review Instead Of Mode Equivalence Testing: Who Are These Experts?
White Paper | By Celeste A. Elash, YPrime

Electronic data collection is fast becoming the preferred method (versus paper) for capturing patient-reported outcome data in clinical trials. This transition necessitated expensive and time-consuming mode equivalence testing. But now, the process of “expert screen review” is being considered as a more efficient and less expensive alternative.

4 Ways To Avoid Failure In Phase 3 Clinical Manufacturing
Article | By Sylvia Tsengouras, Isabelle Lafosse, and Kara Faford, Thermo Fisher Scientific

Understanding the challenges in the biopharma space is critical, as the planning you do today dictates the options you have later when the costs — and the stakes — get even higher.

Monitoring Clinical Trials With Electronic Informed Consent
Article | By Sandra “SAM” Sather and Neetu Pundir, Signant Health

This article highlights some of the monitoring challenges and burdens related to informed consent for a clinical trial and explains how electronic informed consent (eConsent) can positively impact monitoring practices and documentation. The article demonstrates how oversight of data integrity and human subject protection may be improved with an eConsent solution and provides some guidance on considerations when implementing eConsent in a clinical trial to enhance the monitoring process, including saving time, reducing costs, and boosting efficiencies.

Innovation, Quality, And Expertise: Keys To The Post-Brexit Clinical Landscape
Article | By Tom Harris and Kate Godwin-Smith, Cenduit LLC

Many sponsors might have teams dedicated to a post-Brexit clinical landscape — and might have already formulated a plan — but much is still unknown as we enter into new, uncharted territory. For many sponsors, this scenario will be especially relevant for inventory registered within an IRT (interactive response technology) system manufactured and packaged outside the U.K. with the need to be imported in-country. Let’s look at one of the most vital areas of concern: drug depots.

5 Strategies For APAC Drug Submissions: Korea, China, Japan
Article | TransPerfect

Korea, China, and Japan are no strangers to clinical trials in Asia. They have large patient populations and sophisticated regulatory systems and infrastructure, and each has worked to adopt the CTD (common technical document) or eCTD (electronic common technical document) for submissions. That said, they also require the most content to be presented in-language to local regulators. So how do you manage up to five million words of critical content translation across 330 files and submit on time?

The Placebo Problem In Pain Research: Keeping Up With The “Mrs. Joneses”
Article | Premier Research

Pain trials are uniquely challenging because they rely so heavily on patients’ own assessments. While researchers will always need to account for the placebo effect when studying indications as subjective as neuropathic pain, there are ways to increase the likelihood of achieving objective trial outcomes.

LEAN Packaging Process Supports Pfizer’s Urgent Mission To Dose Child With Life-Enhancing Gene Therapy
Case Study | Almac Group

Download this case study to discover how Almac’s LEAN packaging process supported Pfizer’s urgent mission to dose a child diagnosed with Duchenne Muscular Dystrophy (DMD) with a life-enhancing gene therapy.

Actigraphy Motion Biosensors For Dermatology Poster Presentation
Poster | Philips Respironics

This poster demonstrates how the combination of high-resolution actigraphy and advanced signal processing provides an accurate and noninvasive assessment of nocturnal scratching events.

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