Premier News

Data Management & Biostatistics

Premier Research Achieves Medidata Rave Accreditation for Clinical Trial Processes

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.

Premier Research Employees to Support Rare Disease Awareness

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.

Medical and Regulatory Affairs

Premier Research Expands Certification Under ISO Standard for Medical Device and Diagnostics

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.

Other

Premier Research Names Dr. Martin Nicklasson to Board of Directors

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.

Patient and Stakeholder Engagement

Premier Research’s New Rare Disease and Orphan Drug Survey Accentuates Difficulty of Recruiting Patients and Motivating Patients to Take Part in Study

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 Augments Staff in Fast-Growing Pediatrics and Rare Disease Clinical Trials Division

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.