Pulse: Industry Perspectives

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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An exciting year for the medical technology industry

Monday, December 19, 2016

The Pulse on Global Trials by Matthew Howes

In the medical technology industry, 2016 has been an exciting year for R&D. From the development of naturally moving prosthetic limbs that are controlled by the brain to the use of a needle-free vaccine delivery device in Zika trials, medical devices are becoming a major focus in the advancement of human health.

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Social listening or patient panels?

Monday, December 12, 2016

The Pulse on Patient Recruitment by Ashley Tointon

With patient engagement activities ramping up in the clinical trials industry, sponsors are looking at different methods to engage patients. Two popular tactics—social listening and patient panels—are being conducted more regularly to gain insights into patients’ perceptions. Both tactics are valuable to learn from: Social listening is passive listening and patient panels are active engagement.

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Experience and compromise make all the difference

Monday, December 5, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

It is the responsibility of the investigator to delegate to appropriately experienced staff. The scope of practice is defined by education, training and licensure. The investigator must recognize the capabilities and limits of staff to whom he/she has delegated study tasks, and assign accordingly.

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Engaging the underrepresented patient population

Monday, November 28, 2016

The Pulse on Site Success by Christophe Berthoux

In January, the FDA declared 2016 “The Year of Diversity in Clinical Trials” and shared a series of activities planned to advocate for more representation of women and minorities in clinical research. A push for more inclusion requires a community-wide effort; however, sites will play a big part in ensuring diversity, not only in medicines that are tested, but among patients.

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Movember: Bringing men’s health to the forefront

Monday, November 21, 2016

The Pulse on Global Trials by Matthew Howes

Globally, men’s health outcomes are significantly worse than women’s—a paradox, given that more men participate in clinical trials than women. Across the world, men die an average of six years younger than women.

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Go directly to the source—Patients

Monday, November 14, 2016

The Pulse on Patient Recruitment by Ashley Tointon

With more companies working on patient-centric initiatives, it’s a good time to appraise what is being done to enhance the patient’s clinical trial experience. Although there is no agreed-upon definition of the term patient centricity, the premise is to put patients first.

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Always assure proper training in clinical researchers

Monday, November 7, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

The introduction to clinical research is thrilling for new investigators and staff. The opportunity to participate in drug discovery and contribute to the development of innovative disease treatment beguiles like a magical elixir—it can obscure the enormity of the commitment required. There is far more involved in starting a clinical research practice or new research position than a patient database, medical license and the ability to obtain vital signs and draw blood. It is a challenging assimilation of establishing infrastructure, negotiating contracts and regulatory approvals and solidifying sponsor relationships to solicit the trials necessary to support cost.

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