Partnering & Outsourcing Editorial
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The Secret(s) To Solving The Clinical Trials Staffing Crisis
2/10/2023
In September 2022, there were 6.6 million clinical research jobs posted in the U.S. but only 5.7 million available hires. What accounts for the hiring gap, and how can it be narrowed? Kathi Enderes, SVP, research, and global industry analyst, at The Josh Bersin Company explains why looking outside the field is one way to address worker shortages.
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4 Essential Drivers In Clinical Development For Emerging Biotechs
12/21/2022
Enrollment, enrollment, enrollment has been the sponsor’s classic mantra for achieving success in a clinical trial. Rather, we should replace this notion with four equally essential building blocks: 1) the selection of the right CRO, 2) the identification of study sites, 3) the engagement of sites, and 4) the enrollment of patients.
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The Future Of TransCelerate: Clinical Trial Modernization
12/19/2022
In January 2023, Janice Chang will take over as the head of industry consortia non-profit organization TransCelerate. Chang has been involved with TransCelerate since it was just a concept, and notes the time spent in the group since its launch has been an amazing journey.
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Boehringer Ingelheim Implements One Medicine Technology Platform
12/8/2022
For years, Boehringer Ingelheim operated with a system comprised of best-of-breed solutions from different vendor companies. After carefully evaluating the technology environment, the company decided to move from best-of-breed solutions to an end-to-end product development platform.
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How CVS, Walgreens, And Walmart Will Improve Clinical Trial Recruitment
11/30/2022
A new development could potentially change the patient recruitment challenge. In 2022, CVS, Walgreens, and Walmart officially entered the clinical trials space. The patient access capabilities of all three organizations may change the way drug developers access patients while also solving the patient diversity problem.
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Portage Biotech Creates A New Drug Development Model
11/21/2022
While working for BMS, Ian Walters noticed a disturbing trend in the industry. Big Pharma companies would often lament that small biotech firms do not develop drugs the same way it is done at large companies. He is now working to change the biotech model.
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A 3-Point Strategy For Training Part-Time GCP Consultants
11/17/2022
Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.
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What Is A Risk-Based Approach To CRO Oversight?
10/20/2022
Ian Wyglendowski, head of strategic clinical partnering at UCB, recommends taking a risk-based approach to CRO oversight. The first step is understanding the risk that exists. If an inspector walked in today and asked how you, the sponsor, could ensure that an activity you have outsourced complies with ICH GCP regulations, would you know how to answer that question?
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Market Outlook: How Should You Select A CRO Partner?
10/4/2022
Research firm Industry Standard Research has released the latest edition of its Phase II/III Study Trends and Market Outlook (2022-2026) report. The goal of the report is to provide readers with a high-level view of the Phase II/III clinical development space to illustrate current market dynamics and inform strategic planning.
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Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
9/16/2022
Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.