Nicky Dodsworth's presentation, How Can the Laboratory Reach the Standards Necessary for Research, describes how these facilities can apply good clinical laboratory practices to demonstrate that their work meets the quality, reliability, confidentiality, and integrity standards for audit research.
Premier Research’s New Pediatric Survey Reveals Challenge in Identifying Sufficient Clinical Patients
A new survey of clinical trial decision makers commissioned by Premier Research reports that identifying an adequate number of children suitable to be patients is far and away the single greatest challenge in conducting a pediatric clinical trial. The Premier Research survey also revealed a surprising lack of awareness among clinical trial sponsors that, as part of the Safety and Innovation Act (FDASIA), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet specific criteria.
Premier Research has been accredited to the Medidata Rave system for data capture and clinical trial management. The achievement certifies the company to build Medidata Rave databases and include this widely adopted electronic data capture and clinical data management system in its repertoire of offerings to improve clinical trial processes and increase productivity.
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.