Safety Data Exchange Agreements (SDEA)

Manage Pharmacovigilance contracts and SDEA

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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.

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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.

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Features

Creation

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