DURHAM, N.C., June 29, 2017 — Premier Research’s head of quality assurance will speak on life sciences supplier certification during a webcast hosted by The Knowledge Group. The event takes place Thursday, July 20, from 3 p.m. to 5 p.m. Eastern. The Life Sciences’ Supplier and Contractor Qualification and Control Framework Explored will address challenges...
DURHAM, N.C., June 7, 2017 — Premier Research’s leading quality expert will host a panel discussion on risk-based decision-making at the Avoca Quality Consortium’s 2017 summit in Dublin. The discussion, starting at 2:15 p.m. June 8, will address needs in transforming human capital management and improving risk mitigation in clinical trial execution. It’s an ideal...
Good clinical practice (GCP) guidelines govern important aspects of clinical trials to ensure patient safety and scientific integrity. “GCP” is a quality standard which refers to the document put forth by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a group made up of regulatory officials...
DURHAM, N.C., October 9, 2016 — Premier Research’s quality assurance chief will chair a session at the Research Quality Association’s 2016 Annual Conference in Brighton, U.K. Nicky Dodsworth, Vice President of Global Quality Assurance, will lead the session taking place Thursday, November 10, starting at 9 a.m. Stream C, Session 1 at the RQA conference...
DURHAM, N.C., April 05, 2016 – New European Union standards governing clinical research have significant implications for future drug trials. Nicky Dodsworth, Vice President, Quality Assurance, Risk & Compliance at Premier Research, will discuss these changes at the 2016 West and Wales Regional Forum on Innovation and Risk, April 21 in Milton Park, Oxfordshire, U.K. In...
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...
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...
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.
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.