Video

Clinical Research: Phase 1 - Phase 4

Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies

Phase 1 clinical trials aim to determine the maximum tolerated dose (MTD) of a new molecule with the goal of identifying a recommended Phase 2 dose (RP2D), often the MTD itself. Ideally, the RP2D would have adequate therapeutic effect to demonstrate preliminary signs of efficacy in Phase 2, but many Phase 2 trials fail to...

Data Management & Biostatistics

Explainer Video: PremierOne Ecosystem Hybrid Case Study

Today’s technology enables us to seamlessly integrate data for every stage of a clinical trial, from lab results to mobile health apps, patient-reported data, and much more. These new sources of data allow us to better interpret, predict, and quickly turn around a study that may be stalled due to lagging enrollment, regulatory challenges, or...

Clinical Research: Phase 1 - Phase 4

Essential Strategies in Dermatology Clinical Trials: The Convergence of Patients, Regulations, and Study Design

Competition for patients among sponsors in the field of dermatology drug development has never been as intense as it is now — so much so that it’s becoming difficult to meet project timelines, attract and retain patients, and achieve comprehensive study results. Patients are in high demand, and making studies appealing to them — convenient,...

Clinical Research: Phase 1 - Phase 4

A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation

Explore dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical...

Medical and Regulatory Affairs

Developing Best Practices for Forging Strategic Sponsor-CRO Partnerships

Dr. Krista Armstrong, Vice President, Neuro Business Unit and Strategic Development, discusses best practices for forging strategic Sponsor-CRO partnerships. As recorded at OCT New England.

Clinical Research: Phase 1 - Phase 4

The Potential For Disease-Modifying Therapies In Parkinson’s Disease

Parkinson’s disease is a progressive neurodegenerative disease that strikes its victims in the prime of their lives. Most available treatments have remained largely unchanged for years, with Levodopa the “gold standard” for treating Parkinson’s disease for nearly 50 years, with only marginal advances in improving the drug’s efficacy. It also only targets the symptoms, not...

Clinical Research: Phase 1 - Phase 4

Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

The invisible wounds caused by post-traumatic stress disorder can dramatically affect mental health and diminish quality of life. According to the Sidran Institute, a nonprofit organization serving people who have experienced or witnessed traumatic events, PTSD is associated with an extremely high rate of medical and mental health service use. Patients may incur the highest per-capita cost...