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The antithetic Millennial and their impact on innovation detractors

Monday, September 18, 2017

The Pulse on Study Startup by Craig Morgan

By 2025, Millennials will make up the majority of the workforce1. In response, companies are clamoring to understand how to recruit, motivate and retain these workers. But what is the current and expected impact of this demographic on clinical research?

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Upfront planning crucial to process improvements and quality in clinical trials

Monday, August 7, 2017

The Pulse on Study Startup by Craig Morgan

If you fail to plan, you are planning to fail. These words ring true when it comes to study startup (SSU), especially as the clinical trials sector embraces planning as key to boosting study quality. With research showing a continually stagnating timeframe for conducting clinical trials and a trend toward overhauling study performance, quality improvement is moving to center stage. With the availability of workflow-based SSU tools (Figure 1), proactive planning, process optimization and quality improvements—as measured by audit-readiness and the likelihood of passing regulatory audits—are within reach.

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Rising demand for CRAs

Monday, June 26, 2017

The Pulse on Study Startup by Craig Morgan

Demand for Clinical Research Associates (CRAs), professionals whose main function is to monitor clinical trials, is expected to grow 1.52% annually by 2018, which results in many sponsors and CROs finding themselves in a never-ending recruitment cycle for qualified CRAs.

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goBalto, Informa partner on global site selection

Friday, June 16, 2017

goBalto, a provider of cloud-based clinical study startup (SSU) solutions, announced its partnership with Citeline, part of Informa’s Pharma Intelligence vertical, to integrate data from Citeline’s intelligence platforms—including Trialtrove and Sitetrove—with goBalto’s Select. Indexing information captured by Citeline on more than 390,000 investigators across over 265,000 trials in more than 170 countries to the award-winning Select application aids in providing a data driven approach to weighing selection and performance variables in the identification of sites and target populations ideally suited to studies.

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The illusion of safety in study startup

Monday, May 15, 2017

The Pulse on Study Startup by Craig Morgan

Risk is our constant companion, and as clinical trials grow in complexity, so do risk-based challenges to bring new therapies to market at an ever-increasing pace. The continued reliance on Excel, which lacks project- and risk-management functionality, has created an illusion of safety often fueling the rescue study industry.

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Why the cloud is pivotal to speeding clinical trials

Monday, April 3, 2017

The Pulse on Study Startup by Craig Morgan

Clinical trials are growing in complexity, complicated further by the convolution of demand, outsourcing and globalization. According to a recent study by KPMG, within the pharmaceutical industry the return on R&D expenditure has fallen from an industry average of approximately 20% in the late 1990s to just 10% today, while the average cost of developing a drug has risen during that period at a rate of 7.4% higher than inflation, due largely to the cost of conducting clinical trials. The drug discovery process is incredibly inefficient, complex, bureaucratic and, above all else, expensive—with only one out of every 10 drugs that start trials being approved by the FDA.

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INC Research accelerates clinical trial startup with goBalto Activate

Wednesday, March 29, 2017

goBalto, a provider of cloud-based clinical study startup solutions, announced results from its ongoing partnership with INC Research, a global CRO and pioneer in the implementation of goBalto’s end-to-end study startup platform to accelerate delivery of phase I to IV clinical trials for global biopharmaceutical customers. INC Research continues to optimize its clinical study startup process on a worldwide basis, leveraging goBalto’s technology to start more than 220 studies in more than 68 countries to date.

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Overcoming the innovation malaise

Tuesday, February 21, 2017

The Pulse on Study Startup by Craig Morgan

Innovation is often cited as the “key ingredient” by organizations striving to sustain an advantage in the increasingly competitive global marketplace. The pace of technology change is relentless, with those who don’t embrace emerging trends often paying a hefty price. Simply “doing the same thing better,” however, is not enough.

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