Tag: drug development

Clinical Research: Phase 1 - Phase 4

Are We Trading Speed for Innovation in Approving New Drugs?

DURHAM, N.C., February 16, 2018 — Are expedited approvals of new drugs occurring at the expense of innovation? Nach Davé, Vice President of Global Regulatory Affairs at Premier Research, will explore the subject at Outsourcing in Clinical Trials West Coast 2018, February 21 in Burlingame, California. In his presentation, Faster Approvals but Less Innovation: Trend...

Consulting

6 Tips for Strategic CRO-Sponsor Partnerships (And Why They’re Important)

Strategic partnerships between sponsors and CROs are an important part of today’s clinical research landscape. When managed effectively, these relationships provide customers with collaborative strategic resources that drive optimized solutions. Partnerships help ensure the continuity of project teams and operations, development of best practices for continuous learning, and streamlined resource planning and staffing. They can also provide...

Consulting

4 Historical Orphan Drug Development Barriers, Have We Broken Through?

Both understanding the role of patient advocacy groups in building better clinical trials and improving the research process mean first taking a look at the history of orphan drug development in the United States and Europe. An “orphan drug” is a drug that treats a condition that fewer than 200,000 people have. Because rare diseases...

Patient and Stakeholder Engagement

Rare Disease Expert to Discuss Role of Patient Advocates at WODC Europe

DURHAM, N.C., November 16, 2016 — From discovery to approval to market entry, patient advocacy groups are quickly expanding their role in drug development as they target vast unmet needs in cancer and rare disease treatment. One of Premier Research’s rare disease strategists will discuss this trend, and its implications for the industry, at this...

Consulting

Success in Neurodegenerative Disease Trials: Attend Our Nov. 15 Webinar

DURHAM, N.C., November 10, 2016 — Researchers developing treatments for neurodegenerative disorders face some of the biggest hurdles in planning and conducting clinical drug trials. Get advice on navigating this difficult terrain by attending a Premier Research webinar on Tuesday, November 15. Neurodegenerative Disease Research: Steps to a Successful Clinical Trial will describe a complex...

Quality

The Trends Reshaping Medical Device Trials: Attend Our Webinar on Nov. 2

DURHAM, N.C., OCTOBER 27, 2016 — Medical device and diagnostic companies are conducting more clinical trials than ever, a trend that’s giving rise to new procedures and best practices for studies that differ in many ways from pharmaceutical trials. Register for this webinar focused on the evolution of device clinical research on Wednesday, November 2....

Patient and Stakeholder Engagement

Strategic Start-Up: Project Managers Addressing MAGI Conference in Las Vegas

DURHAM, N.C., OCTOBER 3, 2016 — You’re starting a lengthy project that’s fraught with risk and could cost a billion dollars or more to complete. A couple of early missteps might spell disaster. Welcome to clinical drug research. Boost your odds of success with a robust project schedule and carefully executed startup plan. At MAGI’s...

Data Management & Biostatistics

ASA Biopharmaceutical Workshop to Explore Study of Chronic Pain

DURHAM, N.C., SEPTEMBER 29, 2016 — Point-in-time “landmark” analysis, the standard in most chronic pain studies, may not be appropriate for evaluating single-dose drugs. Instead, an analysis strategy similar to that used in acute-pain research may be more effective, Premier Research’s top biostatistics expert will assert in a poster presentation at the American Statistical Association’s...

Patient and Stakeholder Engagement

Gaining Strength: Webinar to Explore Advocates’ Role in Drug Development

DURHAM, N.C., August 10, 2016 — Patient advocacy groups play an important and growing role in developing drugs to treat cancer and rare diseases, contributing to study design, recruiting patients, and even directly funding clinical trials. At a September webinar, Premier Research will team with rare disease advocacy organization Global Genes to explore this important...

Clinical Research: Phase 1 - Phase 4

Informed Strategy Key to Drug Development Innovation, Premier Research Says in Naming Regulatory Chief

DURHAM, N.C., June 27, 2016 — Small biotechnology companies taking new biopharmaceutical products from benchtop to bedside need an informed regulatory strategy and a close working knowledge of the Food and Drug Administration and other regulatory agencies. So when it sought a new head of regulatory affairs, clinical development service provider Premier Research found its ideal...