Pulse: Industry Perspectives

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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A successful CRA is diligent and has help

Monday, January 23, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

What makes a Clinical Research Associate (CRA) successful? Medical training and clinical research experience provide basic fundamentals. Monitoring experience and therapeutic training provide role infrastructure. But experience alone does not distinguish the exceptional from the merely competent. Exceptional CRAs possess intrinsic qualities that define their performance. Some CRAs are effective communicators and can translate complicated medical jargon with ease. Other CRAs have superior data review skills that rival regulatory agency auditors. These qualities are difficult to quantify and are not universal.

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Use and adoption of site-facing technology

Monday, January 16, 2017

The Pulse on Technology by Elisa Cascade

EDC, RBM, SSO, etc.—These three-letter acronyms related to technology are enough to make your head spin. Everyone’s talking about the latest site-facing technology and how it could improve clinical trial operations efficiency, but I thought I would start off the new year (and the new Pulse on Technology column) by setting the record straight on current technology usage by global sites. This will also set us up for future deep-dives into individual clinical trial technologies!

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Moving beyond clinical and operational metrics in study startup

Monday, January 9, 2017

The Pulse on Study Startup by Craig Morgan

Metrics are central to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages. They also drive competitive performance among those organizations performing trials.

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