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for Regulatory Correspondence and Commitments

Form Builder

Form Builder

Easy configuration of contact / correspondence for with complex field definitions, validation and dependencies

Email Intelligence

Email Intelligence

Ingest incoming emails, extract attachments, read them and build a draft response package using CARA AI

IDMP / MDM

IDMP / MDM

Integrate seamlessly with a variety of master data management systems (product information) or manage it in CARA including our RIM and IDMP

Commitments

Commitments

Plan, author, approve and submit Post Marketing Commitments, all linked to the submission / correspondence

Submissions

Submissions

Tie the data into your submission content management system so that correspondence is tied to and easily visible from the submissions

Correspondence and Commitment management made simple

Over 70% of regulatory activity focuses on maintenance of existing products and submissions.  A time consuming and business critical part of this is managing interactions with Agencies and Post-Marketing Commitments.

Contacts with regulatory authorities involve metadata being captured, with intelligent inheritance / pre-population from existing / template forms, together with value assistance across multiple fields, with dependencies based on the process of users. Additionally, contacts often have associated content (emails, documents, faxes, multi-media) which needs to be attached, and routed together.

Being able to then plan and manage Post-Marketing Commitments in the context of the agency interactions and also the submission documents, tied together with CARA IDMP and RIM modules, is very valuable.

Download Data Sheet

FORM INPUT

  • Form configuration including tabs, columns, grids (table of data)
  • Complete the forms using browser or mobile device
  • Values from queries, value lists, dictionaries and Master Data
  • Full range of controls including text, dates, integers, picklists, radio buttons, checkboxes
  • Set fields to be visible, mandatory and/or editable based on conditions
  • Inter-field dependencies
  • Full CSS / HTML formatting
  • Field validation such as date ranges, text string masks and regex validation
  • JavaScript validation

ATTACHMENTS

  • Import or attach documents directly onto forms
  • On saving the form, automatic relationship are built between the form and attachments
  • Clone metadata from forms to attachments
  • View, edit and otherwise work on attachments from the form on in the repository
  • Extract attachments from emails, and extract metadata from documents and emails on import

ROUTING

  • Use Documentum BPM workflow or CARA workflows to route the form and attachments
  • Full lifecycle (Documentum standard lifecycle)
  • Dashboards to report (BAM not required)
  • Synchronise lifecycle state and metadata across forms and attachments in the background
  • Multiple form handling for workflow, status, annotations and more
  • Tie the correspondence to the original submission documents

COMMITMENTS

  • Plan required Commitments
  • Author, review and approve content directly in CARA, in the context of the HA interactions and the original submission documents
  • Track progress of the Commitments
  • Submit and manage RIM information on the Commitments using CARA RIM and IDMP modules

Over 400,000 users and growing…

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