Safety Data Exchange Agreements
Manage Pharmacovigilance contracts and SDEAs
It is a legally mandated obligation for each pharmaceutical company to track pharmacovigilance agreements and contracts relating to pharmaceutical products and the exchange of Adverse Events.
Rather than being a requirement that can be met by a stand-alone contracts management system, this requirement is more complex. CARA allows for the interaction of these contracts with the Pharmacovigilance domain, ensuring consistency and accuracy of data, and reducing manual input and tracking.
Benefits
Create documents and forms with dynamic content
Create contracts and supplier evaluations using document templates, or through the CARA Forms functionality to provide user input screens that are then rendered dynamically to PDF.
Contract approval and eSignature
Full workflow internally in CARA to manage review, approval and eSignature, or to external users / counterparties for eSignature using our CARA integration with DocuSign.
Integrated with PV
Seamlessly linked with Pharmacovigilance on the CARA Life Sciences Platform, or integrated with e.g. ARGUS and ARISg. Output to PSMF.
Full reporting and tracking dashboards
Get email alerts or use the full reporting / dashboards in CARA to track things like upcoming contract expiration, number of contracts per country, total process time for signing contracts etc.
Create documents and forms with dynamic content
Contract approval and eSignature
Create contracts and supplier evaluations using document templates, or through the CARA Forms functionality to provide user input screens that are then rendered dynamically to PDF.
Full workflow internally in CARA to manage review, approval and eSignature, or to external users / counterparties for eSignature using our CARA integration with DocuSign.
Integrated with PV
Full reporting and tracking dashboards
Seamlessly linked with Pharmacovigilance on the CARA Life Sciences Platform, or integrated with e.g. ARGUS and ARISg. Output to PSMF.
Get email alerts or use the full reporting / dashboards in CARA to track things like upcoming contract expiration, number of contracts per country, total process time for signing contracts etc.
Features
Creation
- Create contracts from templates.
- Push metadata into Word documents to populate the contract with e.g. automatically generated contract numbers, counterparty information, and more.
- Utilise the integrations with Brava or the internal CARA features to compare versions / documents.
- Create a contracts package of multiple documents, including a Publish to PDF built into CARA.
- Use the CARA Forms capability to create an input form for Business Partner Evaluations, QA questionnaires, and more.
- Dynamically render the form contents to PDF, including hyperlinks to attachments.
Approval / Third Parties
- Share contracts with external counterparties through use of the email / portal to send.
- Receive back counterparty edits via manual or automated upload to the Staging Area (extracting from emails.)
- Utilise the CARA internal workflows for approval, including eSignature.
- Display signatures as added pages on the contract using the CARA DocSecure module.
- Use the CARA integrations with DocuSign / AdobeSign for digital signature, including individuals who are not system users, e.g. third parties or externals.
Tracing & Integration
- Build CARA Reports to show contracts or other information status by country, month, group, product, or other variables.
- Get automated alerts when contracts are due to expire and trigger automatic workflows.
- CARA Dashboards – show information from inside CARA and from external systems in single reports with graphing.
- Measure and track performance over time without need for separate reporting software.
- Output information directly into a PSMF or in a form ready for manual inclusion.
- Integrate with other systems e.g. Master Data Management, ARGUS, ARISg, Veeva CRM. No integration is required if you are using CARA for these functions as well.
Creation
Approval / Third Parties
- Create contracts from templates.
- Push metadata into Word documents to populate the contract with e.g. automatically generated contract numbers, counterparty information, and more.
- Utilise the integrations with Brava or the internal CARA features to compare versions / documents.
- Create a contracts package of multiple documents, including a Publish to PDF built into CARA.
- Use the CARA Forms capability to create an input form for Business Partner Evaluations, QA questionnaires, and more.
- Dynamically render the form contents to PDF, including hyperlinks to attachments.
- Share contracts with external counterparties through use of the email / portal to send.
- Receive back counterparty edits via manual or automated upload to the Staging Area (extracting from emails.)
- Utilise the CARA internal workflows for approval, including eSignature.
- Display signatures as added pages on the contract using the CARA DocSecure module.
- Use the CARA integrations with DocuSign / AdobeSign for digital signature, including individuals who are not system users, e.g. third parties or externals.
Tracing & Integration
- Build CARA Reports to show contracts or other information status by country, month, group, product, or other variables.
- Get automated alerts when contracts are due to expire and trigger automatic workflows.
- CARA Dashboards – show information from inside CARA and from external systems in single reports with graphing.
- Measure and track performance over time without need for separate reporting software.
- Output information directly into a PSMF or in a form ready for manual inclusion.
- Integrate with other systems e.g. Master Data Management, ARGUS, ARISg, Veeva CRM. No integration is required if you are using CARA for these functions as well.
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