PV Case Management
Automating pharmacovigilance with a modern cloud solution
Intake Processing
Case Management
Reporting
PV cases can be created in CARA from a number of input sources (XML input, emails, manual entry), and then processed to closure, including submission to the NCA using the ICH E2B R2/R3 standard
Benefits
Case Intake Flexibility
Information can come into the CARA case intake from a variety of sources (including emails, XML files, API from another system, manual entry etc), and will create a case. Depending on the case information, notifications will be sent to the responsible parties based on the country / product or other criteria. Additionally, CARA can create a data item / case in third party systems (e.g. SAP) or within e.g. Complaints on the CARA Life Sciences Platform.
Save Time with Automated Case Processing
Cases can be automatically assigned to processors based on market, product, language, severity or any other criteria that you need. As the case moves through its lifecycle, additional fields will become visible and/or mandatory, but for Data Privacy reasons some fields might be hidden from global processing teams and only available for the in-country teams.
Low-Effort Case Reporting
Once cases are ready to be reported, CARA can generate the required XML files using ICH E2B R3 format ready for submission to the Regulatory Authorities.
Case Intake Flexibility
Save Time with Automated Case Processing
Information can come into the CARA case intake from a variety of sources (including emails, XML files, API from another system, manual entry etc), and will create a case. Depending on the case information, notifications will be sent to the responsible parties based on the country / product or other criteria. Additionally, CARA can create a data item / case in third party systems (e.g. SAP) or within e.g. Complaints on the CARA Life Sciences Platform.
Cases can be automatically assigned to processors based on market, product, language, severity or any other criteria that you need. As the case moves through its lifecycle, additional fields will become visible and/or mandatory, but for Data Privacy reasons some fields might be hidden from global processing teams and only available for the in-country teams.
Low-Effort Case Reporting
Once cases are ready to be reported, CARA can generate the required XML files using ICH E2B R3 format ready for submission to the Regulatory Authorities.
Latest Resources
Chemical Management on the CARA Life Sciences Platform
Chemical Management on the CARA Life Sciences Platform CARA streamlines the creation, storage, and lifecycle management of chemicals, raw materials, formulations, and packaging by integrating
The Next 5 Years with James Kelleher
Since founding Generis, James Kelleher has witnessed the company’s transformation from a boutique consultancy into a global leader in content and data management. We caught
CARA Platform Document Management Overview
The CARA Platform: Document Management Overview The CARA Platform streamlines document management processes while ensuring adherence to stringent compliance standards across industries, including life sciences,
