Clinical trials can often take between six and seven years to complete, but that timeline isn’t always practical for the problems pharmaceutical companies are trying to solve. Additionally, six years ...

Clinical trials have become increasingly expensive, time-consuming, and complex, leading sponsors to look for more efficient ways to conduct their business. Risk-based quality management (RBQM) is ...

WASHINGTON--(BUSINESS WIRE)--This week, the Association of Clinical Research Organizations (ACRO)’s RBQM Working Group published a paper in DIA’s Therapeutic Innovation & Regulatory Science journal ...

The interrelated final standards on quality management issued in June 2022 by the AICPA’s Auditing Standards Board and Accounting and Review Services Committee are intended to clarify and improve ...

Editor’s note: This article is the first in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. In June 2022, the AICPA’s Auditing ...

NEW YORK--(BUSINESS WIRE)--Medidata, a Dassault Systèmes company, will be leading multiple sessions at the upcoming Summit for Clinical Ops Executives (SCOPE) on trial diversity, risk based quality ...

In this free webinar, see how a mature and intentional risk-based quality management (RBQM) strategy can drive higher quality and more efficient clinical development programs. Attendees will gain ...

The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the pharmaceutical industry in ...

US and EU officials explained on Wednesday what their respective regulatory agencies look for in clinical trial risk-based monitoring (RBM) and how RBM can impact review times. Under a cooperative ...

To improve the overall safety and performance of medical devices, the United States FDA has proposed an amendment to the Code of Federal Regulations (CFR) for 21 CFR4 Part 820 of the current good ...