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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.

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