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.
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 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.
PHILADELPHIA, March 18, 2013 — Premier Research today announced the addition of four talented clinicians to key leadership roles in its fast-growing pediatric and rare disease clinical trial research disciplines. The Philadelphia-based global contract research organization (CRO) named Dr. Susan P. Tansey, MBCHB, MRCP, CCST, medical director, pediatrics. Her medical specialty areas include vaccines, cardiovascular, and oncology, although her initial training was in neonatology and pediatric medicine. She has considerable experience in pediatric clinical research and trial design.
A new survey of clinical trial decision makers commissioned by Premier Research and involving 50 biotech and pharmaceutical firms in North America and Europe reveals that more than two-thirds (69%) of respondents said that among the most difficult factors in recruiting patients into a rare disease clinical trial was not only finding and motivating patients to join and remain in trials, but identifying and setting up investigative sites for studies.
Premier Research announced today that it will use a new electronic Trial Master File (eTMF) system on all Clinical Development Services Studies. Trial Interactive has been tapped to provide the supporting platform. The adoption of eTMF is the company’s latest investment in its 2012-2013 technology RoadMap focused on three key areas ...
The Pediatric Research Equity Act (PREA)—requiring drug makers to test all drugs for safety and efficacy in pediatric populations as well as in adults—was passed in 2003 and updated in 2007. And in Europe, a similar requirement has been in effect since 2007.
Premier Research’s staff across the United States took part in National Lemonade Days on Friday June 8, 2012. Employees in Austin, Phoenix, Philadelphia, Quincy and Salt Lake City set up lemonade stands at their office locations to raise funds for Alex’s Lemonade Stand Foundation (ALSF).
A new biopharma survey of 55 biotech and pharmaceutical firms in both the North America and European markets by Premier Research reveals that the biggest problem those companies are facing in complying with pediatric regulations is that there may not be enough children who are both accessible and can meet often stringent study criteria to participate in the required clinical trials.