Medical and Regulatory Affairs

Consulting

Premier Insight 268: When Other CROs Said No, We Said Yes – to the Nearly Impossible

The client asked the nearly impossible — a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it. So we...

Consulting

Premier Insight 263: The Case of the Elusive Protocol

A customer asked us to do a chart review of patients with hypophosphatasia, an extremely rare metabolic bone disease with a live birth incidence of about one in 100,000.  The perinatal variant is rapidly fatal. A proliferation of protocols Initially informed consent was required if local regulatory authorities and/or IRBs required it. Then the Premier...

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.

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.

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.