Talking Trials

Our leadership team’s perspective on the latest in CRO and clinical research breakthroughs.

By Michael Sullivan, Senior Research Fellow, Worldwide Clinical Trials,

Small molecule biomarkers provide insight into metabolic pathways related to therapeutic treatment and can help explain the mechanism of action during drug development for an array of therapeutic areas.

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By Miroslav "Misha" Backonja, Senior Medical Director, Worldwide Clinical Trials,

Pain intensity rating, most often administered as a numeric pain rating scale (NPRS), where 0 is no pain and 10 is the worst pain imaginable, has been an essential pain assessment tool in clinical research for decades and in everyday clinical practice for more than a decade and a half when it was introduced as a Fifth Vital Sign.

In clinical practice, it has been a standard and a mandate that clinicians assess pain as a Fifth Vital Sign and also to intervene with the goal to lessen severe pain in their patients.

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By Tomislav Babic MD, PhD,

Early involvement of the gastrointestinal tract in development of Parkinson’s disease (PD) has been indicated by the presence of constipation in the premotor (prodromal) stage of PD. In fact, this is one of the earliest non-motor signs of PD, associated with occurrence of a-synuclein aggregation in gastrointestinal nerve endings forming Levy bodies in the gut several years before classical motor clinical presentation of Parkinson’s disease. Several recent studies of the gastrointestinal tract shed new light the prevention of PD and open avenues for larger neuroscience Parkinson’s disease research projects.

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By Dr. George Atiee, Vice President and Medical Director at Worldwide Clinical Trials Early Phase Services Unit,

At a time when technology is well and truly embedded within people’s everyday lives, the adoption of modern technology within clinical research has been an obvious step forward for the industry. Fifteen years ago, Electronic Data Capture (EDC) in clinical research was still a relatively rare entity. However, fast forward to today’s clinical trials and electronic data capture solutions have a proven track record of supporting studies of all sizes and complexities.

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Phase I pharmacy
By Sherilyn Adcock, Ph.D., Executive Vice President, Worldwide Clinical Trials Early Phase Services,

Following on from part 1 of our series on the role of pharmacy in clinical research units (CRUs) this post provides valuable insights into the role of manufacturing and compounding, investigational drug blinding and dispending and dosing.

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Phase I pharmacy
By Sherilyn Adcock, Ph.D., Executive Vice President, Worldwide Clinical Trials Early Phase Services,

Phase I clinical trials form an important foundation for drug development and eventual approval of life-saving therapies. This two-part blog will review the role of the pharmacy in a state-of-the-art Phase I clinical research unit (CRU) and discuss best practices. Part 1 will consider the importance of pharmacy staff, the novel role of protocol review and drug accountability, with the next installment discussing manufacturing and compounding, investigational drug blinding and dispending and dosing.

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