Clinical Research: Phase 1 - Phase 4

3 Innovations Improving Neuropsychological Testing in CNS Drug Development

Although current limitations in neuropsychological testing may discourage development of treatments for central nervous system (CNS) disorders, some researchers see these unmet needs as an opportunity for innovation. Take a look at three strategies that are improving the validity and viability of neuropsychological testing. Rater Training Success or failure of a CNS trial can come down to...

Clinical Research: Phase 1 - Phase 4

The 7 Most Important Steps for Success in Neurodegenerative Disease Trial Design

When it comes to clinical trials for neurodegenerative disease (NDD), it’s easy to get overwhelmed by complexity. Not only are the mechanisms that underlie NDDs like multiple sclerosis and Alzheimer’s still largely a mystery, their inherent variability is hard to account for. The best way to combat the problem? Break trial design down into more manageable pieces....

Patient and Stakeholder Engagement

Premier Insight 255: Merging Science and Nuance to Treat Post-Traumatic Stress Disorder

When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety...

Clinical Research: Phase 1 - Phase 4

Neurodegenerative Disease Research: Steps to a Successful Clinical Trial

Speakers:Anne-Marie Nagy, Ph.D., Executive Director, Strategic Development, Neuroscience, Premier ResearchTodd Leathers, MBA, Executive Director, Strategic Development, Neuroscience, Premier Research Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Diagnosis alone is tricky, given the often-delayed onset of symptoms, and optimizing study design, recruitment, event adjudication, and biomarker use complicates...

Consulting

A Premier Time with STARR Coalition at CNS Summit

As it was starting to get cold in the Northeast, a group of us snowbirded down to warm Florida for the CNS Summit. Before the conference began, we participated in STARR Coalition’s annual meeting. STARR Coalition is a remarkable group whose mission is to create meaningful change by increasing communication, partnerships, and goodwill among stakeholders...

STARR Coalition Names Premier Research 2016 CRO of the Year

DURHAM, N.C., October 28, 2016 — STARR Coalition, an organization dedicated to treatment, advocacy, research, and recovery in mental health, named Premier Research CRO of the Year at its annual STARR Meeting in Boca Raton, Florida. The group cited Premier Research for its longstanding partnership in supporting the coalition’s mission to serve the mental health...

Premier Research Strategist to Discuss Evolving Site Landscape at CNS Summit

DURHAM, N.C., October 26, 2016 — Premier Research’s lead strategist will participate in a panel discussion on the evolving landscape for investigator sites at CNS Summit 2016 in Boca Raton, Florida. Krista Armstrong, Vice President of Strategic Development, will join colleagues in addressing topics such as: Advantages and disadvantages of site consolidation Site selection and strategic...

Consulting

‘Trailblazers’ needed to combat the agonizing scourge of addiction

Rising addiction rates are adding to already huge unmet needs in treating drug dependence, but big pharmaceutical companies show little interest in developing medications for common dependencies such as cannabis and methamphetamine. This volatile environment begs for trailblazers who can fill the void, but inconsistent patient behavior, lack of clear regulatory pathways, and other factors...

Premier Research Expands Staffing Amid Growing Demand for Neuroscience Studies

DURHAM, N.C., May 23, 2016 — As demand for neuroscience clinical trials grows, Premier Research has named neuroscience expert Dr. Susan Kozauer Senior Medical Director for Psychiatry. Kozauer joins recent hires Anne Marie Nagy, Ph.D., Dr. Teresa Nunes, Dr. Carol Gaines, and Todd Leathers on a team that has performed almost 400 neurology and psychiatry...

Medical Director Authors Novel Look at Kleefstra Syndrome

DURHAM, N.C., April 1, 2016 — A paper authored by a Premier Research medical director takes an unprecedented look at motor function and behavior in adults and children with Kleefstra syndrome. Susanne Schmidt, M.D., Ph.D., and four Norwegian colleagues published their findings in the European Journal of Medical Genetics. The study of four male and...