Partnering & Outsourcing Editorial
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Dispelling The Misconceptions Of Conducting Clinical Trials In Russia
10/8/2021
Russia is a growing area for clinical trials. In 2018, 654 new trials were approved in Russia. Approximately 50% of those trials were initiated by multinational companies led by Novartis, Roche, Pfizer, Janssen, Abbvie, AstraZeneca, and Merck. Oncology trials led the way with 114 trials, followed by rheumatology and neurology.
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How AstraZeneca’s Clinical Trials Procurement Team Adapted To The Pandemic’s Demands
10/7/2021
The pandemic has tested AstraZeneca’s Global Operations organization to ensure clinical trials continue. As a function, procurement plays a key role across this supply chain, with a strong emphasis on assuring supply of product on time and with solid service by third-party suppliers to respond to any shifts in demand. Here's how AstraZeneca's procurement team successfully adapted.
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What Is Scientific Research Misconduct & Fraud In Clinical Research?
10/5/2021
What does scientific misconduct and fraud truly mean in the context of clinical research? And what are the ramifications for those at fault? This article provides an overview as well as common findings from the DOJ and FDA.
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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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What Risk-Based Oversight Of GxP Vendors Is & Is Not In Clinical Trials
9/2/2021
Some pharmaceutical companies still have a notion that delegating responsibility for a clinical trial to a vendor is a way to transfer risks related to the delegated duties and functions. Nothing is further from the truth. This article examines what is vendor oversight in the context of ICH's GCP (R2) guideline.
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A Stem Cell Company Overcomes The Challenges Of International Trials
8/26/2021
Performing global trials presents challenges that drug developers do not face in the U.S. Those challenges need to be considered and addressed in the planning process. Jim Joffrion, senior director of clinical development and operations for Athersys, discusses the challenges and the importance of the CRO selection process.
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Could An Incentive-Based Pricing Model Improve CRO Performance?
8/24/2021
When speaking to clinical executives, I will often ask about their likes and dislikes around various pricing models they have experienced. I also ask about those features they would most like to see in a pricing model, especially if they had the opportunity to design one from scratch. Here is some of the feedback I received.
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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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The Four Essential Pillars of Successful Patient Centric Trials
8/12/2021
Praxis Precision Medicines is a drug development company using genetic insights to focus on treatments for patients with CNS disorders. Praxis has patient centricity infused throughout the organization and believes taking care of patients and producing successful trials comes down to four essential factors: staff, sites, CROs, and patient insights.
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Best Practices For Setting TMF Expectations With Your CRO
8/12/2021
Developing a strong relationship and setting up-front expectations with your chosen CRO are critical keys to success in clinical studies. While the RFP process will assist in framing the contractual relationship between sponsor and CRO, it is unlikely to outline your detailed operational expectations. Follow these best practices to avoid confusion and resentment, and to make sure your CRO will satisfy your expectations.