Clinical Audit Research: Ensuring that Laboratories are Meeting the Standards

PHILADELPHIA, September 29, 2015 — More and more, clinical laboratories are called on to handle and analyze samples for clinical audit research. These laboratories are accredited for routine clinical work, but how do they ensure the quality of these non-routine activities?

Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, examines this question at the IBMS Quality Conference 2015 in Birmingham, U.K. Her 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.

Dodsworth reviews the main areas of focus in preparing for an inspection or audit: vendor assessment and ongoing management; challenges in communicating among sponsors, laboratories, and contract research organizations; the importance of the escalation process; and understanding the metrics that define expectations for quality, timeliness, and delivery.

Dodsworth also will speak at the forthcoming conferences:

  • European Forum for Good Clinical Practice (EFGCP), Oct. 13, Prague, Czech Republic, presenting: The Protocol and QbD
  • Research Quality Association (RQA), Nov. 11, Leeds, U.K., presenting: Working Towards a Smarter Tomorrow
  • Institute of Clinical Research, UCL, Nov. 20, London, co-presenting: Key GCP Updates

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.