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Eclantiqx Life Sciences & Pharmaceuticals Services

Eclantiqx partners with life sciences and pharmaceutical organizations to accelerate drug development, streamline regulatory compliance, and ensure product quality through Pega’s low-code Digital Process Automation platform and specialized industry expertise.

Clinical Trials & Research Operations

  • Trial Start-Up Automation: Orchestrate site qualification, contracts, and IRB submissions.
  • eCRF & eSource Integration: Stream data from sites, wearables, and EDC systems in real time.
  • Protocol Change Management: Automate amendment approvals, distribution, and training updates.
  • Patient Recruitment & Retention: Use AI to match eligible participants and automate follow-up workflows.
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Regulatory Affairs & Submissions

  • eCTD Publishing Hub: Automate document assembly, validations, and regulatory publishing.
  • Global Submission Tracker: Centralize timelines, approvals, and agency communications.
  • Label Management Integration: Synchronize labeling changes with submission dossiers.
  • Automated Compliance Monitoring: Continuous rule checks against global regulatory standards.

Pharmacovigilance & Safety Surveillance

  • Safety Case Intake Automation: Integrate reports from portals, call centers, and literature.
  • Rule-Based Triage & Escalation: Automate SAE workflows and regulatory notifications.
  • Periodic Reporting Factory: Generate PSURs/PBRERs using compliant templates.
  • Signal Detection Analytics: Leverage machine learning to identify safety trends proactively.

Manufacturing & Supply Chain Integrity

  • Electronic Batch Records: Automate recipe management, execution, and review with audit trails.
  • Supplier Quality Management: Digitize qualification, audits, and CAPA workflows.
  • Inventory & Serialization Hub: Track materials and products with end-to-end traceability.
  • Change Control Automation: Route engineering change orders with digital approvals and impact analysis.

Quality Management & Compliance

  • Digital QMS Platform: Manage deviations, CAPA, and change control in a unified system.
  • Automated Investigation Workflows: Route tasks, notifications, and corrective actions.
  • Audit-Ready Reporting: Dashboards and templates for FDA, EMA, and other agency inspections.
  • Training & Certification Tracking: Automate course assignments, attestations, and expiration alerts.

Whether you’re a startup or an enterprise, we partner with you to co-create solutions that are bold, adaptive, and future-proof.

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