Pulse: Industry Perspectives

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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Grasping for innovation: Where should industry look?

Monday, October 30, 2017

The Pulse on Patient Recruitment by Ashley Tointon

As technology progresses at a rate hard to keep up with, many in the clinical trials space struggle to be innovative while desperately wanting to try something new. Clinical trial recruitment is a difficult endeavor; removing barriers to participation is a priority. One way to make things easier it to try innovative ideas that make things less complicated for patients. These can be simple solutions like eConsenting or eDiaries, or can be as complex as fully remote trials using telemedicine technology.

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Calling all clinical research personnel

Monday, October 23, 2017

The Pulse on Global Trials by Matthew Howes

In recent years, a global talent shortage has hampered strategic growth for many organizations. According to the ManPower Group, 36% of employers globally report talent shortages, the highest in seven years.

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Site impact of new ICH/GCP guidelines

Monday, October 16, 2017

The Pulse on Site Success by Christophe Berthoux

The industry largely accepts ICH/GCP guidelines as the gold standard regarding conduct in clinical research, which was recently updated in response to the increasing use of technology as well as findings from regulatory inspections. In November 2016, the second revision to ICH Good Clinical Practices E6 R2 contained an integration of 26 new additions to serve as guidance for clinical study conduct.

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There’s a lot of ways to leave a good impression

Tuesday, October 10, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

There is no better learning opportunity than to observe an experienced individual correctly complete a process that you are trying to understand/implement outside of a classroom in a real-world environment. It lends depth to the sometimes-lifeless instruction of written curriculum. The demonstration tames the daunting unknown, creating confidence in an ability where there may have been none. It shows diversity of technique and timing, and expands that which is preconceived about an untried task.

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Electronic trial applications and the next phase of site interactions

Monday, September 25, 2017

The Pulse on Technology by Elisa Cascade

The relationship between sponsors, CROs and clinical trial sites is a crucial aspect of clinical trial success. Historically, most trial communication has happened in person or via fax, but over the past 10 to 15 years, communication has largely shifted to email. Today, with the increasing popularity of electronic trial applications, sponsor, CRO and clinical trial site interactions are now beginning the next phase of process transformation with access to study resources, facilitated workflow and transparency for all parties.

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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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Examining the nuances of patient engagement versus recruitment

Monday, September 11, 2017

The Pulse on Patient Recruitment by Ashley Tointon

Patient engagement and patient recruitment are two very different activities that often intersect. Engagement activities often involve broad solicitation of feedback to understand how a particular disease state affects a person’s daily life. The engagement to solicit feedback can come in many forms such as speaking engagements, patient panels or online surveys. Patient recruitment consists of the strategy and activities to increase clinical trial awareness among specific populations. Understanding the differences and the intersection points of patient engagement and patient recruitment can lead to a more appreciative look at not simply why we need the information, but how the information can be used to inform and transform clinical trial design.

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Paying attention to rare disease markets

Tuesday, September 5, 2017

The Pulse on Global Trials by Matthew Howes

The market opportunity of rare diseases is tremendous. Experts predict global sales of drugs with orphan designations will reach $176 billion by 2020. Biopharma as an industry is collectively investigating some 450 different orphan drugs, demonstrating the strategic value inherent in the category. But with over 6,000 rare diseases affecting an estimated 350 million people around the world, they have only just begun to tap the full market potential.

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