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As Arena International’s Outsourcing in Clinical Trials New England conference gets underway this week in Boston, Massachusetts, Clinical Trials Arena will highlight all matters clinical outsourcing. Only months after our last focus on outsourcing clinical trials, due to popular demand, CTA will once more draw attention to the most pressing concerns facing industry professionals.
Be sure to visit us tomorrow when James Sherley, Founder and Director of Asymmetrex, exposes a problem that is crippling progress in stem cell medicine. On Wednesday, another CTA regular, Ken Getz from Tufts CSDD examines why the sponsor-CRO dynamic often falls short of expectations.
Later in the week, Lisa Henry, Manager of Clinical Research at Cordis, discusses the merits of clinical trial outsourcing models. And lastly, Daria Wicks, Director of Clinical Operations at Vericel Corporation, emphasizes the importance of clear communication between sponsors and CROs alike. So as you can tell, a deluge of topics will be explored on CTA, so be sure not to miss out this week!
In the meantime, catch up on our last Outsourcing Week in May where we featured some of the industry’s most prominent experts… (click on the headline to finish reading).
For years, variants of Risk-Based Monitoring (RBM) have been implemented within sponsor organizations to carry out their data management activities. With all the rage these days centered on how innovative technologies can disrupt study processes, questions are abound as to what impact that will have on the way companies collect patient data.
In the case of RBM in particular, with machine learning and AI coming to the fore, will the industry need a rethink on how it identifies risk in clinical trials?
In this Industry Viewpoint, CTA Editor Henry Kerali sits down with Dr Craig Elliott, who’s the Global Head of Operations at Clintec International. An expert on technological advancements, Elliott explains why the industry needs to hit the reset button on RBM and adopt what he calls a ‘data-driven’ approach.
The announced acquisition of Parexel in May 2017 by private equity firm Pamplona Capital Management represents a denouement for the top four market-leading contract clinical research organizations (CROs). Quintiles, Covance, Parexel and PPD have each now experienced a change of ownership. The owners are strategic partners, well-positioned within the broader health care and life sciences arena, and private equity investors with considerable capital and broad life sciences portfolios. In all cases, the acquiring companies are not clinical research insiders.
The use of biomarkers in clinical trials can aid operational efficiencies in drug development that as of yet, haven’t been fully realized – arguably, it must be said. But how can biomarkers best be leveraged to reduce timelines and altogether bring drugs faster to market?
In this Industry Viewpoint, Irene Mayorga Ruiz of QUIBIM sits down with Henry Kerali to discuss the importance of biomarkers. An experienced professional, Ruiz is a biomedical engineer who specializes in obtaining imaging biomarkers from medical images with treatment response value. Here, she explains how biomarkers can be incorporated into clinical trials and be fully maximized.
We all love trends; fashion trends, music trends, twitter trends, you name it. In clinical trials it is no different – we love our trends. Be it patient centricity, risk-based monitoring, digitization, adaptive trials or analytics. However, we sometimes fail to see and plan for the impact these trends can have on the way we outsource our work. Below we will look at five of the current biggest clinical trial trends and see how each may impact clinical outsourcing decisions, and potentially create trends of their own.
If one studied the role of data manager as it is today and compared it to what the role entailed in, say, the 1970s, then what’s irrefutable is how the role has markedly changed over the years. Whereas before you had trial master files (TMFs), now you have electronic TMFs. Before you had patient reported outcomes (PROs), and now things have gone digital with ePROs.
As technologies advance, so too does the industry – no matter how seemingly slow it embraces change! But how will the industry, and more specifically, data managers adapt to the technological advances that lie in wait?
In this Industry Viewpoint, CTA Editor Henry Kerali sits down with Dr Raphalea Schnurbus, who’s the Clinical Solutions Director at OPIS. Here, she explains how data managers, from sponsors and CROs alike, must stay on their toes as the industry readies itself for the next technological paradigm.