Experts from Premier Research will examine how regulatory changes are affecting clinical trials and medical device makers when they chair two sessions at the DIA 2015 51st Annual Meeting, June 14-18 in Washington, DC.
Join Nach Dave and Carol Huntington of Premier Research for Orphan Drug & Rare Disease Development: Understanding the European and US Regulatory Landscape. The hour-long event, beginning at 11am EDT, 4pm BST, and 5pm CEST, is aimed at researchers and pharma companies tackling some of the 7,000 rare diseases identified by the National Institutes of Health.
A new survey of clinical trial decision makers commissioned by Premier Research reports that nearly two-thirds (64%) of respondents said that among the most difficult factors in recruiting for a rare disease or orphan drug clinical trial was not only finding patients to join and remain in trials, but identifying and setting up investigative sites for studies.
Premier Research will present a speaker and host two roundtable sessions at the World Orphan Drug Congress, April 22-24 in Washington, DC. The Philadelphia-based contract research organization is a platinum sponsor of the fifth annual event, a top meeting place for biopharma, biotechs, government, patient groups, and others.
Premier Research and Alexion Pharmaceuticals will co-present a webinar on achieving uncommon success in rare and ultra-rare disease studies on Wednesday, March 11, at 11am EDT (NA) / 3pm GMT (UK) / 4pm CET (EU-Central).
7,000 rare diseases, many untreatable. 50% of patients are children. 35% of deaths in the first year of life are due to rare diseases. To everyone at Premier Research, that’s a call to action. So Premier Research employees worldwide will join together on Friday, February 27, to raise awareness of Rare Disease Day 2015.
On Monday, June 30, 2014, Premier Research expanded its ISO certification as a provider of strategic and regulatory consulting, clinical development, and post-marketing surveillance services to manufacturers of medical devices and diagnostics. This certification includes ISO 9001:2008 and aspects of ISO 13485:2003, the key quality management standards required by international regulatory authorities and—therefore—by Premier’s customers.
On Thursday, June 12, 2014, Premier Research announced that a panel of their experts will discuss the design of pediatric studies, recruiting for pediatric research, and the importance of corrective and preventive actions to a company’s quality system at the 2014 Drug Information Association conference, June 15–19 in San Diego.
On Wednesday, May 28th, 2014, Premier Research announced the appointment of Martin Nicklasson, Ph.D., to its board of directors. Nicklasson brings to Premier Research a wealth of international experience in the biopharmaceutical sector, both at the executive and at the board level. A native of Sweden with a doctoral degree from the University of Uppsala, Nicklasson held positions in pharmaceutical development, R&D management, and global marketing, as well as franchise management in Astra, Kabi Pharmacia, and AstraZeneca. He became the CEO of AstraZeneca (Sweden) before moving on to the biotechnology sector as the CEO of Biovitrum.
Sherri Hubby, Director, US Quality Assurance, will present “A Global Perspective from Ethics, Accreditation Bodies and Industry on Conducting Clinical Trials to Ensure Compliance” on Tuesday, March 27 at 16:00. With the increased challenges that come with conducting clinical trials in global markets and shortened timelines, many groups must work together to achieve balance and build public assurance. This session will review how quality programs are being conducted to assess compliance and to ensure consistency of ethical review and decision-making despite cultural differences. Practical information will be shared including how to identify gaps for managing clinical trial weaknesses and audit readiness tips.