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 ...
Explore resources and examples that explain how small firms can perform monitoring procedures, document results, and turn ...
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 ...
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 ...
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 ...
While security threats evolve and challenges to managing organizational risk become more seemingly every year, the foundation of securing the business is knowing and understanding its vulnerabilities ...
If you’re running a quality building — strong staffing ratios, engaged leadership, residents thriving — you know the frustration. One abuse scandal three states away, and suddenly your census takes a ...
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