Pulse: Industry Perspectives

Building the site/sponsor/CRO relationship through the feasibility process

Monday, October 3, 2016

The Pulse on Site Success by Christophe Berthoux

Clinical research studies are becoming increasingly complex with studies that may have challenging inclusion/exclusion criteria, urgent timelines or competing studies. These are only a few factors that increase the potential for delays and which have significant implications regarding time and cost. Delays can severely impact an organization. The most effective means of mitigating the risk for delays is conducting a comprehensive clinical trial feasibility assessment.

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The long road of multiple sclerosis research

Monday, September 26, 2016

The Pulse on Global Trials by Matthew Howes

Multiple sclerosis (MS), a chronic, autoimmune, inflammatory neurological disease of the central nervous system, is the largest neuro disease affecting young people. In MS, the immune system attacks the protective sheath, called myelin, that covers nerve fibers. Communication between the brain and the body becomes disrupted and nerves become damaged.

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Tactics for recruiting diverse patient populations

Monday, September 19, 2016

The Pulse on Patient Recruitment by Ashley Tointon

Patient Recruitment strategies are not the same for all patient populations. The recruitment strategies that work well in a phase III psoriasis study will not be the same as those that work well for a phase II pediatric type 2 diabetes trial. Recruitment strategies will differ among different genders, ethnicities, incomes and ages. In order to develop a sound strategy, you first must understand your audience and then dive deeper to understand preferred mediums and uncover credibility factors that should be considered in the messaging and the medium of recruitment activities.

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The key to drug development success is collaboration

Monday, September 12, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

Bridging drug discovery to drug development is a fundamental tenet in clinical research conduct that requires strategic collaboration. Successfully bridging investigational site relationship discovery to site development requires the same critical collaboration from study startup to study conclusion, and all pivotal points in between. The investigational site/study team dynamic will positively or negatively drive site performance in a clinical trial, and successful stewardship is key to this outcome.

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The CRO-site relationship: Gaining interest and momentum

Tuesday, September 6, 2016

The Pulse on Site Success by Christophe Berthoux

A great deal of emphasis has traditionally been placed on the sponsor-site relationship and the sponsor-CRO relationship; however, given the complexities of the current clinical research environment, these relationships are being redefined. CROs have recognized the importance of developing new approaches in order to ease the administrative burden typically placed on sites.  

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The many roles that contribute to patient recruitment

Monday, August 22, 2016

The Pulse on Patient Recruitment by Ashley Tointon

Recruiting patients into a clinical trial takes careful planning and flawless execution from multiple sources. Although the site is often responsible for contributing the majority of patients needed to meet enrollment targets, there is not one single person or role that is ultimately responsible for patient recruitment. Principal investigators, study coordinators, clinical research associates (CRAs), sponsors, CROs, feasibility analysts, patient recruitment specialists and consultants all play a role.

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The meaning of a 483: An opportunity for growth or label to be feared

Monday, August 8, 2016

The Pulse on Site Success by Christophe Berthoux

An FDA Form 483 may not be new, but it still brings fear of the unknown, regardless of tenure, to the clinical research industry. The implications of receiving a Form 483 are perhaps perceived differently by stakeholders, and some sites lack clarity regarding the purpose and anticipated results surrounding a Form 483.

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The hunt for an HIV vaccine

Monday, August 1, 2016

The Pulse on Global Trials by Matthew Howes

In the 1980s, HIV was a death sentence. Today, three decades later, clinical research has produced therapeutic breakthroughs that have turned HIV into a chronic yet manageable disease. Drugs that approach the disease from different angles, in combination with each other, are able to reduce viral load—the amount of virus in the body—to levels that are undetectable.

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Develop a patient recruitment strategy the right way

Monday, July 25, 2016

The Pulse on Patient Recruitment by Ashley Tointon

When recruiting patients for clinical trials, multiple things can go wrong. The majority of us have likely encountered at least one horror story involving huge patient recruitment budgets that resulted in miniscule measurable results. These pervasive stories enable the continuation of a commonly held feeling of skepticism about the value of patient recruitment services. The “when things go wrong” story is passé and should be replaced with the “when things go right” story. One of the best ways to ensure patient recruitment success is to set up the program correctly from the start.

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