Monthly Archives: February 2017

Despite advances in the orphan drug development process and the more prominent role that patient advocacy groups now play, researchers in this area still face a number of challenges. But, fortunately, increased collaboration between patient groups, industry leaders, and regulatory bodies can help overcome these hurdles. Barriers to orphan drug research include: Small population By definition,Read more

Rare diseases present some unique obstacles for researchers that significantly contribute to the high cost of drug development. Fortunately, innovations in biomarker use have the potential to significantly cut back on these costs while improving data quality. However, before biomarkers can be used in this research, their associated collection, measurement, and evaluation methods must be validated. The key phases of biomarkerRead more

In clinical drug research, time is of the essence. Not only are researchers, in many cases, trying to beat their competitors to market, their ability to conduct a timely clinical trial can be the difference between life and death for the target audience. The question is, then, how do you as a sponsor get your contract research organizationsRead more

DURHAM, N.C., FEBRUARY 22, 2017 — Premier Research will share new insights on rare oncology drug development at a webinar on Tuesday, February 28. From Laboratory to Bedside: Expediting Development of Novel Rare Cancer Treatments (11 a.m. EST / 4 p.m. GMT / 5 p.m. CET) will examine how new processes and regulatory pathways areRead more

DURHAM, N.C., February 20, 2017 — Premier Research is a presenting sponsor of this year’s Outsourcing in Clinical Trials West Coast conference in Burlingame, California, and two company executives are speaking at the event. Dr. Colin Hayward, Chief Medical Officer, will speak on moving oncology molecules to proof of concept on Wednesday, February 22, atRead more

One of the most rewarding efforts I’ve seen in my years working with Premier Research is watching our Rare Disease Day activities unfold. Every year we ask our employees to support Rare Disease Day in some way, so we can all remember how crucial our role is in clinical development, especially in this area ofRead more

With increasing demands for evidence of clinical efficacy and safety, applying sound research practices to medical device development is crucial for a product’s success. The Need for High Standards in Study Design When bringing a new medical device to the market — or even reevaluating an existing product — device companies must answer to: Regulators placing greater scrutiny onRead more

The Path to Medical Device Trial Success: Attend Our February 14 Webinar DURHAM, N.C., FEBRUARY 10, 2017 — The medical device regulatory environment is changing as regulators, physicians, health systems, and even patients seek more assurance that products are effective and safe. Premier Research will examine this evolution, and its implications for device makers, atRead more

Dealing with difficult situations is part of the job for project managers in any field, but clinical project managers (CPMs) must overcome a number of unique obstacles on the way to successful study completion. Read on for some of the biggest issues facing project managers today, as well as a few practical strategies for resolvingRead more

DURHAM, N.C., February 8, 2017 — Premier Research announces the appointment of Nina Baluja, M.D., as Senior Medical Director for Medical Services. Dr. Baluja will perform medical and safety monitoring on clinical research projects and provide strategic guidance on protocol development, study design, regulatory filings, and study execution. A pharmaceutical physician with more than 15Read more

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