Tag: drug development

Premier Research and InSilicoTrials Partner to Leverage In Silico Modeling and Simulation and Optimize Regulatory Pathways for Rare Disease Therapies

MORRISVILLE, N.C., MILAN, ITALY, TRIESTE, ITALY — Premier Research, whose mission is to help the most innovative biotech and device companies take their best ideas from concept to commercialization, and InSilicoTrials, a leader in the use of artificial intelligence (AI) and computational modeling and simulation (CM&S) to accelerate development of new therapies and medical devices, have...

PM360: How COVID Has Reshaped the Clinical Trial Regulatory Landscape

The concept of patient centricity is hardly new, but in recent months it has assumed new urgency as industry and regulators have had to adapt to an evolving landscape. The evolution is spurring substantial changes in how clinical trials are developed and implemented, as regulators revise their processes and issue updated guidance documents to encourage...

TrialSite News: Joining the Revolution in Dermatology Drug Development: Tips for Successful Clinical Trials

Skin diseases are the fourth leading cause of health afflictions, affecting nearly 900 million people worldwide. It’s not surprising, then, that there has recently been a noticeable increase in dermatology drug development. There are currently thousands of dermatology clinical trials planned or already launched, including a variety of programs investigating innovative, targeted therapies. Much of...

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...

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...

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....

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...

Premier Research Bolsters Rare Disease and Oncology Drug Development Expertise with New Hires

DURHAM, N.C., June 13, 2016 — Premier Research is expanding its international organization of experts in rare disease amid continued growth in the field — especially in rare oncology, which has surpassed one-third of the company’s rare disease work. “Development of novel compounds for treatment of unmet medical needs historically has been overlooked by big pharma,...