Tag: quality assurance

Data Management & Biostatistics

Discover the Vital Intersection Where Data Ops Meets Quality Assurance at SCDM

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,...

Data Management & Biostatistics

ICH GCP Update: Sponsor Control of Clinical Trial Data

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...

Global Compliance

Updates to the Guideline for Good Clinical Practice: Quick Review

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...

Quality

Quality Assurance VP Speaking at Life Sciences Webcast July 20

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...

Data Management & Biostatistics

Quality Expert to Discuss Data Integrity at DIA Annual Meeting

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...

Consulting

Risk-Based Decisions Topic of Panel Talk at Quality Consortium

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...

Global Compliance

7 Sponsor Responsibilities Under Good Clinical Practice Guidelines

Sponsor responsibilities under good clinical practice (GCP) guidelines are extensive. While many of these tasks may be — and often are — transferred to a contract research organization (CRO), the sponsor is ultimately responsible for study quality. But just what do sponsors need to make sure their clinical trial meets GCP standards? Read on to find out....

Quality

Premier Research Global Quality VP Chairing Session at RQA Annual Conference

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...

Quality

The Trends Reshaping Medical Device Trials: Attend Our Webinar on Nov. 2

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....

Medical and Regulatory Affairs

Europe’s New Trial Regulations: Quality VP to Address 2016 West and Wales Forum

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...