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Quality

GCP Guideline Updates: What are the Implications? Find out Nov. 20 in London

PHILADELPHIA, November 20, 2015 — Proposed updates to the International Conference for Harmonization Good Clinical Practice guidelines would be the most significant changes to international clinical research guidance in 20 years. What’s changing, and how will it affect you? Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will discuss proposed revisions to...

Data Management & Biostatistics

The Ethical Challenges of Adaptive Design: Join a Premier Research Webinar Nov. 19

PHILADELPHIA, November 10, 2015 — What happens when a widely recognized advance in clinical trial design poses ethical questions? Find out Thursday, Nov. 19, at a complimentary Premier Research webinar, Ethical Considerations in Adaptive Design Clinical Trials. The hour-long event, starting at 11 a.m. EST / 4 p.m. BST / 5 p.m. CET, will examine particular...

Data Management & Biostatistics

A Smarter Tomorrow: How CROs Can Produce Better, More Objective Data

PHILADELPHIA, October 21, 2015 — Clinical research must produce consistent, reproducible results to be of real value. But too often, underlying decisions are based on opinions and not on well-defined, objective criteria, complicating things and making objectivity impossible. Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will address this issue at the...

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.