Ennov CTMS
Efficiently manage clinical trials with Ennov CTMS. Unified platform, pre-integrated with eTMF and EDC, customizable workflows.
April 21, 2023
Ennov Doc for Regulatory
Effortless Regulatory Submission Documentation. Preconfigured document inventory, intuitive interface, efficient search capabilities.
April 21, 2023
Ennov EDC
Simplify Clinical Data Collection with Ennov EDC. Configurable edit checks, allowable values library, and pre-integrated with eTMF and CTMS.
April 21, 2023
Burden to patients
The additional load that a clinical activity imposes on patients above that which would be experienced under normal clinical practice. Source: (CIOMS XI: Patient involvement
April 21, 2023
Burden of a risk minimisation activity
Burden is defined as the additional load that a risk minimisation activity imposes on (1) patients, (2) carers, (3) the healthcare system including health care
April 21, 2023
Boxed warning (“black box warning”)
A warning that appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks. Not all health authorities implement
April 21, 2023
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.
April 21, 2023
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December 20, 2023