Quality

What Makes a Good Protocol Template? Premier Research Addresses Meeting in Prague

Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will address those and other questions Oct. 13 when she presents The Protocol and QbD at the European Forum for Good Clinical Practice’s Risk-Based Management of Clinical Trials workshop in Prague. Dodsworth’s presentation at 11:30 will set the scene for the event’s afternoon session on understanding and assessing risks in a sample protocol.

Quality

Clinical Audit Research: Ensuring that Laboratories are Meeting the Standards

Nicky Dodsworth's presentation, How Can the Laboratory Reach the Standards Necessary for Research, describes how these facilities can apply good clinical laboratory practices to demonstrate that their work meets the quality, reliability, confidentiality, and integrity standards for audit research.

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.

Clinical Research: Phase 1 - Phase 4

Measuring How Well Subjects Know and Do in CNS Trials

Central nervous system (CNS) disorders represent a major medical challenge and a significant opportunity for therapeutic innovation. Sponsors who have a clear understanding of the regulatory landscape and neuropsychological testing modalities available are poised to address critical unmet needs for the millions of people living with CNS conditions. Central nervous system (CNS) conditions, including psychiatric,...

Clinical Research: Phase 1 - Phase 4

Measuring How Well Subjects Know and Do in Neuropsychiatric Trials

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.

Medical and Regulatory Affairs

Premier Research to Present at the 24th Annual EuroDIA Meeting

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.

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 ...