Pulse: Industry Perspectives

Health disparities and clinical trial patient recruitment

Monday, December 11, 2017

The Pulse on Patient Recruitment by Ashley Tointon

Despite remarkable improvements in the number of people with healthcare coverage and the vast improvements in many healthcare technologies, not everyone in the nation has benefited equally. Individuals who are low-income, a racial/ethnic minority or who are disadvantaged or disabled typically do not get involved in cutting-edge medical research. 

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Social listening platforms shaking up the marketing

Monday, November 27, 2017

The Pulse on Site Success by Christophe Berthoux

Advancements in clinical research with the adoption of evolving technology has brought many new opportunities to patient recruitment. The industry is experiencing considerable trends that are changing the way researchers find, screen and retain patients. These developments, such as the ability to geotarget specific regions or monitor real-time data, have led to increased efficiency in identifying patients.

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Relationship sustainability—It’s the bigger picture

Monday, November 20, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

In clinical research, we are taught to always move forward—through change to a better process, through error toward the true lesson. Our industry is constantly evolving: risk-based monitoring, ClinicalTrials.gov, social media for patient recruitment. Progress has made us so efficient with accomplishing the short-term goals (interim analysis deadlines and query resolutions) that it can take our sight off of the bigger picture tasks that, though more time-intensive, have a longer-lasting impact. Relationship development is one of these. 

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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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