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.
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.
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 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).
New Survey Reveals Companies’ Concerns About Too Few Pediatric Patients for Clinical Trials Premier Research’s Survey Also Reveals Confusion About PREA and Its EU Counterpart
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.
Premier Research participated at the ACRP 2012 Global Conference, April 16-18 in Houston, Texas. Dr. Charlene Sanders, M.D., Vice President, Global Regulatory Affairs & Pediatric Strategic Consulting and Angi Robinson, Executive Director, Clinical Trials Management led a session entitled “Successful Pediatric Studies: Key Study Design and Site Selection Considerations.”