Video

Clinical Research: Phase 1 - Phase 4

Pursuing Parkinson’s Disease Gene Therapies: Strategies & Operational Requirements

While treatment of Parkinson’s disease has traditionally been limited to dopamine replacement therapy to alleviate symptoms, gene therapy studies have recently evaluated both non-disease-modifying and disease-modifying transgenes for Parkinson’s disease (PD) treatment, with encouraging results. Non-disease-modifying therapies have improved symptomatology, and disease-modifying strategies – including stopping PD-mediated cell death and/or regenerating lost neurons – show...

Clinical Research: Phase 1 - Phase 4

Considerations to Improve Patient Outcomes in Early Drug Development

Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes. Topics in this...

Clinical Research: Phase 1 - Phase 4

Premier Research: Not Just Life Science. Amazing Science.

This life is amazing. Each step. Each gaze. Alone, or together as one, from deep inside, comes who we are. Part science. Part magic. Amazing. Always moving toward the light of discovery. Driven by what’s yet unmet. Across the world around us, decoding the secrets of the worlds within us. We go where that work...

Clinical Research: Phase 1 - Phase 4

Premier CTMS: The Central Organizing Principle for Successful Studies

Across the industry, most trials don’t have access to real-time results…which leads to delays. 95% of those delays last longer than a month. Addressing this challenge means tackling the underlying problems of data being held in disparate places, and failure to predict and address risk. Our Premier One Ecosystem captures all the data related to...

Clinical Research: Phase 1 - Phase 4

Premier Study Start-Up: Where a Successful Trial Launch Begins

Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up. Premier Research developed the Premier One Ecosystem to create a paperless, electronic data process, start to finish. Trials begin with our Study Start-Up application, which automates collection of ALL the data related to your trial, then optimizes it to decrease cycle times...

Clinical Research: Phase 1 - Phase 4

Pathways to Expedited Drug Development in the U.S. and Europe

Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It’s essential to start with the end firmly in mind, identifying the target population and defining elements of the program long before you dose the first patient. This webinar will show you where to start and how to envision...

Clinical Research: Phase 1 - Phase 4

Product Development On‑Demand Webinar Series

Planning a product development program? Learn how to set the stage for success with our on-demand webinar series. The steps you take in the earliest stages can profoundly influence your product’s path through development and marketing approval. When is the right time to engage regulators? Which paths to expedited development make sense for your product?...

Clinical Research: Phase 1 - Phase 4

LSX 2021: The Path From Preclinical to and Through Clinical

Presented by: Peter Larson, Vice President, Medical Affairs for Hematology-Oncology Angi Robinson, Vice President, Specialty Areas April Marquick, Cell and Gene Therapy Expert Originally presented at the 2021 LSX World Congress virtual conference, this webinar series by Premier experts in oncology, rare disease, and cell and gene therapies focuses on development considerations for advanced therapies,...

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...