goBalto

Accelerating trials from the outset

Monday, November 6, 2017

The Pulse on Study Startup by Craig Morgan

Research from the Tufts Center for the Study of Drug Development (CSDD) indicates that starting clinical trials from site identification through to activation is highly inefficient, with cycle times that have not budged in over two decades. Not surprisingly, study startup (SSU) has been receiving renewed focus from pharmaceutical companies under intense pressure to reduce timelines and abate the rising costs of drug development. The globalization of clinical studies has added an additional layer of complexity as differing regulations, limited infrastructures and cultural differences weigh heavily on study sponsors. These factors highlight the growing importance of technology solutions in stemming the tide.

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The Gold Rush and Monopoly Land grab in eClinical growth

Wednesday, November 1, 2017

In 2015, the global eClinical software market was forecasted to reach $6.8 billion by 2020. Recent research now doubles that estimate by 2024. The global increase in clinical trials is driving this growth, as the industry evolves from its slow paper-based methods and standalone spreadsheets toward automated, cloud-based systems to confront the oft-mentioned costs of drug development.

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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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Site selection a continuing conundrum

Friday, September 1, 2017

For many companies, searching for clinical trial sites begins with a look at paper-based and spreadsheet tools that document where they had held earlier trials. Returning to familiar sites allows clinical trial teams to work with principal investigators with whom they have built relationships over time.

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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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