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Understanding Clinical Trial Disclosures
The Growing Field of Regulatory Policy & Intelligence
Anne Marie Finley, Managing Expert, YourEncore Regulatory Center of Excellence defines Regulatory Policy & Intelligence in Part 2 of her Expert Q&A.
Defining Regulatory Policy & Intelligence
Anne Marie Finley, Managing Expert, YourEncore Regulatory Center of Excellence defines Regulatory Policy & Intelligence in Part 1 of her Expert Q&A.
Understanding the RTF Letter - White Paper
Strategic Planning in Clinical Trials and Drug Supply
Jason Nolte, Clinical subject matter expert, discusses the importance of strategic planning teams and what they must utilize to stay relevant in the Clinical Trial & Drug Supply industry.
Bioethics: Application and Implementation
In this Expert Q&A session, Luann Van Campen, Ph.D., M.A., and Don Therasse, M.D., provide valuable insights into the implementation of bioethics best practices within life sciences organizations.
The Clinical Development Plan - Ensuring Success; Part 1: Developing the Clinical Strategy
The Clinical Development Plan - Ensuring Success; Part 2: Executing the Clinical Strategy
Audits: A Brave New World, Time for a Refresh?
Written by Jane Wood, this is an abbreviated version of an article in The RQA Magazine about the rapidly evolving world of clinical trials and the technology and data that rule within them.
Good Laboratory Practices - The Importance of Preparation and Execution
Deb Sedor, former Director of Quality Assurance at J&J, and Managing Expert for YourEncore’s Quality CoE, discusses the importance of preparation and execution when it comes to Good Lab Practices.
Compliance, Clinical Operations, or Quality: What Team Do You Play For?
Some pharma professionals need a gentle reminder that they are, in fact, on the same team – driving toward the same goals. Read more from Arti Bajpai about quality and compliance in a team setting.
Quality Management Systems: A Business Imperative
Quality management used to be about completing checkbox audits, meeting compliance requirements, and correcting problems after the fact. Read our FREE White Paper to learn more.
Good Clinical Practice: Serious Breach Process
Jane Wood, YourEncore's Quality Center of Excellence Principal, discusses a vital component of patient safety when assessing the Quality of an organization's GCP process.
Data Integrity - It's All About the Data!
Jane Wood, Principal of YourEncore's Quality Center of Excellence, discusses the importance of Data Integrity in any Quality system.
Clinical Regulatory Inspections – and why I love them
Jane Wood, Principal of YourEncore's Quality Center of Excellence, discusses the importance behind clinical regulatory inspection readiness.
Quality Best Practices From an IT Perspective
Tony Ettwein, Managing Expert of YourEncore's Quality Center of Excellence, provides valuable insights into audits in IT and the different AI systems that will soon affect the Quality landscape.
A Call to Action for Impactful Clinical Audit Reports
Jane Wood, Principal of YourEncore's Quality Center of Excellence, discusses what constitutes a great audit report.
State of the Industry: The Evolution of Quality and its Upcoming Challenges
Jane Wood, former Head of R&D Quality at J&J, and Principal of YourEncore’s Quality Center of Excellence discuss the current state of Quality and the future of regulation adaptation.
Has Anything Really Changed in Clinical Quality?
Read about some shifts and changes in the Clinical Quality landscape, authored by Jane Wood, YourEncore's Quality Center of Excellence Principal.
For FDA Inspection Readiness, Accountability is Key