Premier News

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.

Adult Drug Studies Play Important Role as Need for Pediatric Research Grows

Jennifer Strickler will describe the main differences between pediatric and adult study designs, outline the medical considerations pediatric protocols should include, and break down protocol elements specific to children and family participation.

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.

Patient and Stakeholder Engagement

Premier Research’s New Pediatric Survey Reveals Challenge in Identifying Sufficient Clinical Patients

A new survey of clinical trial decision makers commissioned by Premier Research reports that identifying an adequate number of children suitable to be patients is far and away the single greatest challenge in conducting a pediatric clinical trial. The Premier Research survey also revealed a surprising lack of awareness among clinical trial sponsors that, as part of the Safety and Innovation Act (FDASIA), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet specific criteria.

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.

Medical and Regulatory Affairs

What’s New in Regulations? Premier Research Chairing 2 Sessions at DIA 2015

Experts from Premier Research will examine how regulatory changes are affecting clinical trials and medical device makers when they chair two sessions at the DIA 2015 51st Annual Meeting, June 14-18 in Washington, DC.