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SDEA Generis
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Safety Data Exchange Agreements (SDEA)

Manage Pharmacovigilance contracts and SDEA

Safety Data Exchange Agreements

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 due to the need to interact with PV systems, which helps ensure consistency and accuracy of data, and reduces manual input and tracking. CARA provides this.


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 contracts from templates

  • Push metadata into Word documents to populate the contract with e.g. automatically generated contract numbers, counterparty information

  • 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 e.g. 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 / externals

Tracking & 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 including 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 – unless you are using CARA for these as well then no integration is required


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