Entities and Agreements

MANAGE ORGANIZATIONAL RELATIONSHIPS AND PV AGREEMENTS (SDEAs)
  • Key features

  • -Manage agreements with partners, affiliates etc. Or configure the organization to control the remit of departments in the application. The entity setup effectively controls the access to data across the entire platform

  • -Setup Authorities, Investigators, Committees etc. and use in other modules e.g. to auto-distribute SUSARs by linking with Clinical Studies and Submissions - or for ICSR regulatory submissions

  • -Auto-generate SDEA documents, format using Word templates

  • -Snippets control standard clauses that can be selected for inclusion into the agreement

  • -Electronic signature allows for fully digital workflows

  • -Link to PSMF module, to populate Annex A, B and C

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