Project Management

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...

Consulting

Six Issues to Consider for Rare Disease Pre-IND Meetings

Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. Pre-IND meetings with the FDA give sponsors the opportunity to discuss their unique development challenges and determine where regulatory flexibility can be justified. While the...

Project Management

Pharmaceutical Outsourcing – Fueling Success: The Sponsor-CRO Partnership

Clinical trials can be dauntingly complex. The high-stakes culmination of years – sometimes decades – of research, they involve rigorous data requirements, close regulatory scrutiny, intricate logistics, and intense cost pressures. Add the stress of trial outcomes sometimes being a make or break proposition for the sponsor, and it makes sense to hire a professional...

Project Management

PM360 – Best Practices for Forging Strategic Sponsor-CRO Relationships

A true strategic partnership has benefits for both the sponsor and the contract research organization (CRO). The partnership is grounded in working together towards a common goal, and for both the sponsor and the CRO the success of one is the success of the other—with processes and talent evolving on both sides to produce enhanced...

Project Management

Come Together: The Foundational Team for your Heart Valve Study

An effective team is critical to the success of any clinical study. And when your product is destined for a market valued at $4-16 billion—such as the AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) markets—you want to ensure a particularly strong foundation for your study. You build that foundation with your...

Consulting

Heart Valve Studies: 6 key players required for success

As market demand for AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) has exploded, companies face increasing pressure to rapidly deliver actionable clinical trial data. The key to success lies in the team. And the foundation of an effective team begins by understanding each role—and, where applicable, how to best select each...