Overview What is GxP? GxP refers collectively to several different types of “good practice” quality guidelines and regulations, each serving a specific purpose. In pharmaceutical product development, these include but are not limited to: GCP (Good Clinical Practice)GLP (Good Laboratory Practice)GMP (Good Manufacturing Practice) GxP standards broadly cover what are commonly referred to as the...
Join us at SCDM 2018 for a session chaired by Sara Doolittle, Associate Director of Data Operations While quality assurance and data operations are generally considered separate entities in clinical drug research, in theory and in practice they are intertwined at multiple levels involving numerous stakeholders. Sara Doolittle, Premier Research’s Associate Director of Data Operations,...
Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data. The recent update of...
First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects. The objective of the standard is to ensure that...
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 19, 2017 — Data integrity has been a prime focus of pharmaceutical regulators for two decades now, but the focus is sharpening markedly with issuance of new guidance from multiple regulatory authorities. Sherri Hubby, who leads quality assurance, risk, and compliance at Premier Research, will address this trend and its implications at...
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...
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., OCTOBER 27, 2016 — Medical device and diagnostic companies are conducting more clinical trials than ever, a trend that’s giving rise to new procedures and best practices for studies that differ in many ways from pharmaceutical trials. Register for this webinar focused on the evolution of device clinical research on Wednesday, November 2....
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...