Pulse: Industry Perspectives

Free up sites to focus on patients, not payments!

Monday, April 10, 2017

The Pulse on Technology by Elisa Cascade

At a conference a few months ago, I spoke with a clinical trial investigator who complained that he still received paper checks in the mail from some sponsors and CROs, often with little or no information as to which protocol or trial procedure it referred to. It got me thinking. Why are we making this so hard for sites? Site personnel aren’t payments experts. They don’t want to spend time tracking down payments. They don’t have the technology expertise to care about how the payments are done. They just want their money deposited in their bank account on time, and with the associated documentation that explains what the payment is for. This is standard across other industries, so why should it be different for clinical trials?

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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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The importance of providing education and awareness surrounding biosimilar products

Monday, March 13, 2017

The Pulse on Site Success by Christophe Berthoux

It has been seven years since the passing of the Biologics Price Competition and Innovation Act, a provision of the Affordable Care Act that created the approval pathway for biosimilars in the U.S. To date, four biosimilar products have been approved by the FDA, compared to 23 products in the European Union where biosimilars have been in play since 2007.

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The benefits of wearing many hats in clinical research

Monday, March 6, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

Anyone seeking a consistent and predictable work environment would likely not pursue a career in clinical research. The compassionate person who wants to impact humanity and cure disease, an intellectual who desires an important role in the drug development process, a person who longs to travel and work outside the 9-5 corporate structure—these are the people who pursue a career in clinical research. Once that career starts, two exultant feet hit the ground running, pausing only to breathe, learn and feel grateful for the opportunity.

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Electronic informed consent: The star bench-warmer?

Monday, February 27, 2017

The Pulse on Technology by Elisa Cascade

“If you build it, they will come.” While this was clearly the case in the baseball film “Field of Dreams,” the same does not hold true for all site-facing clinical trial technology. As the last Pulse on Technology column highlighted, several technologies are still sitting on the bench when it comes to use across all trials. This column takes a closer look at the technology with the lowest awareness and adoption: electronic informed consent (eConsent). To continue the baseball analogy, picture eConsent as a little boy sitting on the bench waiting to get into the game.

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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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Changes in recruitment

Monday, February 13, 2017

The Pulse on Patient Recruitment by Ashley Tointon

Looking retrospectively, patient recruitment activities have evolved greatly. Unfortunately, some issues are cyclical and see resurgence from time to time. Sending in-person recruitment assistance to sites, leveraging patient advocacy outreach and the increased use of videos are just a few examples of valuable tactics that come in and out of popularity, much like recycled fashion. Is this because we don’t disseminate learning? Is it because we run out of new ideas to solve old issues? Realistically, there are many old patient recruitment problems that have yet to be properly solved. Two major issues yet to be solved are the awareness of clinical trials and how to engage with patients.

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Chance needed in mental health clinical trials

Monday, February 6, 2017

The Pulse on Global Trials by Matthew Howes

Clinical development for mental health therapies remain an unmet need. Over the past decade, government-funded research initiatives in advanced countries have lagged in the area of mental health, and the private sector hasn’t succeeded in filling the gaps.

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Areas of focus for research sites in 2017

Monday, January 30, 2017

The Pulse on Site Success by Christophe Berthoux

As 2016 came to a close, many of us spent time reflecting and forecasting for the next year. The clinical research industry has continued to experience significant change and 2016 was no exception. We explored many topics, most notably patient-centricity, methods aimed at streamlining processes and proactive ways to handle study startup. These themes will continue to remain industry discussion topics and new site models will set trends moving forward.

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