Premier Perspectives Blog

Insider Insights in Clinical Development

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 factorsRead more

Introducing Tales from the Road, a series of blogshorts, where our Premier People report in from their travels outside the office. Because sometimes, not everything that happens on the road stays on the road! Today’s inaugural post comes from Juliet Moritz, Executive Director, Strategic Development Department, Rare Diseases, reporting back on her trip to Amsterdam lastRead more

Over the course of more than 20 years in clinical research, I’ve sat in on more study budget development and negotiations meetings than I can count. What I’ve learned from those many thousands of hours of discussion is, whether you’re working with a global pharma company or a biotech start-up, the ultimate success of aRead more

“Speed without quality – like the quality of a swimmer’s stroke during a race – just doesn’t get you the win that you’re aiming for.” – Krista Armstrong, VP for Strategic Development Krista was talking about quality in patient recruitment in our latest webinar, but really it’s a thought that covers all areas of psychiatric clinicalRead more

There are more than 7,000 known rare diseases, and these conditions afflict an estimated 30 million Americans (almost one in 10). Worldwide, some 350 million are living with a rare disease. But for 95 percent of these conditions, there are no FDA-approved treatments — not one. Conventional wisdom holds that innovation follows need: that ifRead more

When selecting a CRO partner, sponsors usually focus on organizational experience – how long the company has been in business, its areas of therapeutic expertise and the breadth and depth of its service offerings. But, sponsors sometimes forget to ask about specific team experience. What do you know about the core study team members –Read more

Quality and effective risk management are vital to every clinical trial, and their importance is greater still when working in rare indications. Your patient population is small, vulnerable, and geographically dispersed, so there’s limited data and little opportunity to replicate clinical trial results. It’s as if the phrase “get it right the first time” hadRead more

Our growing understanding of cancer’s genetic and molecular origins is fueling rapid gains in rare oncology research. Rare cancer therapies accounted for more than 40 percent of FDA orphan drug designations in 2014, and increasing international cooperation among big pharma, biotech, and academia is making this research more efficient than ever. We examine trends andRead more

The challenges of greater regulatory scrutiny, complex logistics, downward cost pressure and increasingly rigorous data requirements are just a few of the reasons biotech and pharmaceutical companies look to outsource clinical trials. In a dynamic healthcare and regulatory environment, outsourcing increases flexibility by streamlining clinical trial management and enabling sponsors to concentrate their resources onRead more

Thanks for visiting the newest addition to our website, our Premier Perspectives blog! Our goal?  To give Premier People the chance to share and discuss their industry insights and ideas with customers, colleagues, patients, employees, and basically, anyone who’s interested in clinical research. We believe in improving productivity in clinical development, and sharing our ideas and bestRead more

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