Welcome to Ennov Insider
Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.
Global eCTD Regulatory Updates
The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.
Future-Proofing Quality Management: A Guide for SMBs in Life Sciences
For small and mid-sized life sciences companies, maintaining quality standards amid constant industry evolution is an uphill battle. With limited
AI and Its Impact on Life Sciences
Discover how Generative AI is revolutionizing drug development, healthcare, and regulatory compliance, shaping the future of the industry.
Unified Quality and Regulatory Information Management
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
Best Practices: Master Data Management
Learn how master data management impacts regulatory affairs. Explore the importance of RIM and IDMP integration for data quality, compliance.
Going Paperless: Best Practices for Creating Certified Copies
In this white paper, we explore the regulatory requirements, processes, and best practices related to creating certified copies of original documents within an eTMF system.
IDMP Considerations in 2022: Interoperable Structured Data Reporting
Interoperable structured data is increasingly burdensome for pharmaceutical companies. This white paper examines some real examples of interoperable structured data and provides some recommendations to prepare for future changes.
Completeness, Quality and Timeliness: A Deep Dive
This paper will examine the KPIs of Completeness, Quality and Timeliness in more detail in order to assist organizations in improving the quality and understanding of these metrics and their roles in risk management, continuous process improvement, and compliance.
White Paper: Clinical Analytics: The Journey from Problem Identification to Solution
Risk-based clinical quality may require information from: the CTMS and eTMF, but also from the EDC, ePRO, RTS, RIMS, and QMS.
eDMS and IDMP
Learn about the interactions between eDMS and IDMP to gain insights into the best practices regarding data governance and IDMP compliance.
eDMS and Office 365 Integration
Learn how Ennov Doc’s integration with Office 365 drives innovation through collaborative authoring.
White Paper: Unified CTMS and eTMF
Learn the key areas where a unified CTMS and eTMF can result in the greatest benefit.