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Pharmaceuticals & biotechnology

Drug Safety Case Intake & Follow-up

Coordinate suspected adverse-event intake, missing-information follow-up, qualified medical review and approved reporting records.

Request a tailored demonstrationExplore the interface

12 workspace menus · 5 role profiles · Connected records

Designed for drug safety operations directors

Drug Safety Case Intake & Follow-up workspace interface preview; illustrative records and figures.
Drug Safety Case Intake & Follow-up — operational workspaceInterface preview · Illustrative dataView full interface →

Explore the system interface.

Operational workspace and record review. Select a screen to inspect it in full.

Drug Safety Case Intake & Follow-up workspace interface preview; illustrative records and figures.
Drug Safety Case Intake & Follow-up — operational workspaceInterface preview · Illustrative dataView full interface →
Drug Safety Case Intake & Follow-up record interface preview; illustrative records and figures.
Drug Safety Case Intake & Follow-up — record and workflow reviewInterface preview · Illustrative dataView full interface →

Operational dashboards and work queues.

Operational views

Review work, evidence, exceptions and authorised decisions within a defined operating scope.

Site / programmePeriodAssigned teamReview state

Dashboard measures

  • Active operational records
    Count of all records in the selected workspace.
  • Review queue
    Records at the third stage of the business workflow.
  • Needs attention
    Records with an assigned review requirement.
  • Final-stage records
    Records in the fourth business workflow stage.

Business workflow and operating scope

Coordinate suspected adverse-event intake, missing-information follow-up, qualified medical review and approved reporting records. A safety case can lose important context as source reports, follow-up requests and review decisions move between teams. The system connects intake to case closure with accountable review steps, preserving the source evidence and the approved reporting position for each case.

Operational visibility

  • Safety cases completed within reporting timelines
  • Risk and obligation dashboard
  • Open issues / alerts
  • Periodic review due list
  • Decision and remediation audit

Operations

Operational overview

Review the work position and priority actions.

Safety report intake

Coordinate safety report intake with assigned responsibilities, linked records and review history.

Source evidence records

Coordinate source evidence records with assigned responsibilities, linked records and review history.

Follow-up requests

Coordinate follow-up requests with assigned responsibilities, linked records and review history.

Medical review routing

Coordinate medical review routing with assigned responsibilities, linked records and review history.

Coding records

Coordinate coding records with assigned responsibilities, linked records and review history.

Reporting task tracking

Coordinate reporting task tracking with assigned responsibilities, linked records and review history.

Case closure review

Coordinate case closure review with assigned responsibilities, linked records and review history.

Insights

Reports and saved views

Review the reporting scope and export agreed operational views.

Governance

Approvals and exceptions

Review delegated decisions, exceptions and recorded conditions.

Audit history

Trace accepted changes, decisions and accountable actions.

Access and configuration

Manage the agreed role permissions and configurable operating rules.

The end-to-end business journey.

From intake to authorised completion, with evidence at each decision.

01

Receive the report

Receive suspected adverse event report.

02

Complete source information

Collect missing source information.

03

Route qualified review

Route medical review and coding.

04

Track approved reporting

Track approved reporting and case closure.

Governance and control

  • Authoritative obligations and thresholds must be version-controlled.
  • High-risk cases require designated reviewer approval.
  • Automated alerts may prioritise but must not silently make accountable regulatory decisions.
  • Evidence and decision rationale must be retained.
  • Periodic reviews must be scheduled from risk and policy rules.
  • Jurisdiction-, regulator- or authority-specific rules must be configurable and validated by an authorised domain owner before production use.

Accountable roles

Safety intake officer
Follow-up coordinator
Qualified medical reviewer
Reporting officer
Quality reviewer

Permissions are configured and tested for the agreed responsibilities.

Data, interfaces and operating requirements.

Core records

Obligation / ruleSubject / entityAssessmentAlert / issueReviewDecisionRemediationEvidence

Systems and interfaces

  • Validated safety systems
  • Licensed terminology services
  • Approved reporting interfaces

Interface scope, data mapping and testing are agreed for each engagement.

Implementation requirements
Requires validated safety systems, licensed terminology and jurisdiction-specific reporting rules; qualified reviewers determine causality, seriousness and reportability.

Mobile and tablet access

Responsive intake or reviewer access can be scoped under approved privacy and validation requirements.

Access approved workflows through the Dalfin mobile app. Device tasks and permissions are confirmed for the deployment.

Apple App Store ↗Google Play ↗

AI extensions

Prepare a draft evidence summary for medical reviewer confirmation. Causality, seriousness and reportability remain qualified-review decisions.

AI extensions are scoped around the required data, business outcome and review controls.

Engineered with Genesis.

Structured application engineering

Connect requirements, roles, records, workflows and interfaces through the agreed Genesis engineering process.

Controlled changes

Review dependency impact and validation requirements. Context Memory supports governed changes and accepted application revisions.

Deployment and support

Agree customer cloud or on-premises requirements, device access, implementation acceptance and ongoing engineering support.

An example operating scenario

See the process, its exception and the evidence.

A suspected adverse-event report lacks source information. The coordinator issues a follow-up request, the qualified reviewer records the medical assessment and approved coding, and the reporting officer tracks the authorised reporting tasks before closure.

What to review

  • A saved end-to-end transaction
  • An exception and its authorised resolution
  • Different operator, approver and reviewer permissions
  • Final records, history and the relevant report
Discuss this solution

Questions before implementation.

How is this system adapted to our organisation?

Roles, approval authority, business rules, records and reporting are configured around your operating model. Scope definition connects the required business outcome to workflows, interfaces and acceptance criteria.

How are approvals and responsibilities defined?

Operators, reviewers and authorised decision makers have defined responsibilities. Approval limits, exception handling and access permissions are agreed with your business owners and tested against the selected workflows.

Can it connect with our existing systems?

Interface requirements cover your existing business systems, data ownership, mapping and authentication. Connection design and testing form part of the agreed implementation scope.

What will we review in a solution walkthrough?

Start with a relevant business transaction, then review its approvals, an exception, role permissions and final records. Discuss the integrations, reporting and operating requirements that matter to your organisation.