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.

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.

Data Management & Biostatistics

Premier Research Announces Adoption of eTMF System

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 ...

Medical and Regulatory Affairs

Premier Research Survey Finds Many Sponsors Ignore Pediatric Requirements for Clinical Trials

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 Helps Fight Childhood Cancer One Cup at a Time

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).

Medical and Regulatory Affairs

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.

Consulting

Premier Research Experts Led Pediatric Session at ACRP 2012

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.”

Other

Premier Research Names Sean Russell Vice President, Marketing

Premier Research Group announces the appointment of Sean Russell to the position of Vice President, Marketing. In this position, Mr. Russell will have global responsibility for leading and developing global marketing at Premier Research.

Clinical Research: Phase 1 - Phase 4

Premier Research Names Etienne Drouet Executive Director, Oncology Europe

Premier Research Group announces the appointment of Etienne Drouet to the position of Executive Director, Oncology Europe. In this position, Mr. Drouet will play a leading role in the operations, strategic planning and corporate development of Premier Research’s growing portfolio of oncology business.

Clinical Research: Phase 1 - Phase 4

Premier Research Names Susan Stansfield, Ph.D. Executive VP, Clinical Development, Strengthens Premier’s Operational Delivery on Worldwide Projects

Premier Research Group announces the appointment of Susan C. Stansfield, Ph.D. to the position of Executive Vice President, Clinical Development. In this position, Dr. Stansfield will have global responsibility for leading and developing the company’s clinical trial management services provided to the biopharmaceutical industry.