Clinical Trial Technology Editorial
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Traditional Trials Are Dead – Virtual Trials Are The Future
9/3/2021
It’s no secret that decentralized clinical trials, also known as virtual trials, are one of the hottest technology trends in the clinical space. Although this trial model has been touted by vendors for many years, it took the emergence of the COVID-19 pandemic in 2020 to get many companies scrambling to implement the new approach.
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How CRO-Sponsor Partnerships Spurred Innovation In 2020
8/24/2021
The clinical research industry in 2020 speedily adapted its practices to accomplish remarkable feats of rapid and high-quality vaccine and therapeutic development. This was atypical for the industry. To study this transition, the Avoca Industry Survey in 2020 focused on practices related to clinical research innovation, and in this article we draw from the data to explore the role played by CRO-sponsor relationships.
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A Proactive Approach To Preparing For The Release Of ICH E6
8/5/2021
Approximately 25 years ago work began on a document intended to revolutionize and improve the efficiency of new drug development. The document, dubbed ICH E6, was intended to provide guidance for clinical trials conducted around the world. ICH E6 is quickly becoming a reality and sponsor companies need to be prepared for it.
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How Otsuka Uses Decentralized Trials & Real-World Evidence
8/3/2021
Prior to joining Otsuka in 2019, Christoph Koenen spent two years with GSK, 10 years with Novo Nordisk, and eight years with BMS. I recently spoke to him about some of the key lessons he’s learned over the years and how Otsuka is applying new clinical trial strategies and technologies, especially for the treatment of patients in mental health trials.
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Otsuka Believes Digital Technologies Will Drive Patient Outcomes
7/29/2021
While other companies scrambled to implement clinical trial-related technology to deal with the pandemic, Otsuka was an early adopter of tools such as eCRF and eConsent. Christoph Koenen, EVP and chief medical officer at Otsuka Pharmaceutical Companies (U.S.) explains how digital technologies will continue to drive patient outcomes.
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4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma
7/29/2021
The clinical quality management systems approach developed 20 years ago is not sustainable in the today’s industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.
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The 6 Pillars Of Effectively Managing Up In Clinical Development
7/22/2021
Managing up, regardless of title, can be a challenging skill to master from the onset. Laurie Halloran and Michelle Pratt of Halloran Consulting share their 6 key lessons that they've learned along their careers in clinical development. This article will help you manage your relationships with your colleagues in a more senior role, while also positioning yourself for success.
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No CMOs Or CROs: A Unique Approach To Cell Therapy Development
7/22/2021
Cartesian Therapeutics has just 20 employees, but the company performs all its preclinical and regulatory work and clinical operations in-house. A few years ago, Cartesian also built a GMP manufacturing facility from the ground up. That gives the company its own quality management system and quality control labs. Learn how they do it.
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Diversity In Clinical Trials: 10 Strategies To Increase Minority Enrollment In Oncology Trials
7/20/2021
Ethnicity, age, and sex can all impact safety and efficacy of any medication in people. Hence, diversity among clinical trial participants is critically important. This article shares 10 interventions to ensure participation of underserved groups to enhance diverse clinical recruitment.
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eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?
7/13/2021
When the pandemic started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Now, as the U.S. is in a summer characterized less by COVID and more by time spent with family and friends, are we willing to face COVID’s hard lessons?