Data Management
Good Manufacturing Practices: When Do They Apply?
Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.
Developing a Data-driven Feasibility Process
Assessing feasibility in clinical research is vital for success, enabling organizations to make informed decisions and ensure seamless execution and reporting of studies.
Key Items Auditors Look for When Reviewing an Investigator Site File
Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:
DSMB Best Practices and Behind the Scenes Insights
Enhance clinical trial oversight with expert insights on member selection, bias elimination, and regulatory compliance from 20+ years of leadership experience.
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
Implementing eSource: A Guide for Operations and Technology Roles
Explore the transformative power of eSource in clinical research, streamlining data collection for efficiency and cost savings.
Operationalizing Research Analytics: Today, Tomorrow, Someday
Uncover how analytics, artificial intelligence, and machine learning are reshaping the foundational elements of clinical research.
Unpacking The Role of a Right-Sized QMS in Study Startup
Discover the crucial role of a customized QMS in streamlining and optimizing study startup processes.
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
Tracking an Effective QMS: From Discovery Through Post Study
Explore strategies for sponsors and CROs for implementing an enterprise phased QMS assessment, and address deficiencies in compliance and implement corrective actions.
Understanding Various Site Use Cases for eSource and EDC
Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance.
Advantages and Considerations for an eRegulatory Implementation
Gain an understanding of what an eReg system is and the features available to streamline clinical trial regulatory management.
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