Zelthy Application Templates

Zelthy Application Templates is a library of 45+ pre-built application templates covering the life sciences value chain, from patient support programs and advanced therapy logistics to regulatory submissions and compliance monitoring. The platform targets pharmaceutical and life sciences organizations that need to deploy functional, configurable software quickly, with templates described as deployable in 4–8 weeks. Many templates incorporate AI capabilities for tasks such as adverse event detection, document review, risk scoring, and demand sensing.

Templates are organized across six functional categories: Patient Services, Advanced Therapies, Commercial Operations, Traceability, Compliance, and Regulatory Affairs. Each template ships with a defined set of workflow modules and can be extended with additional capabilities.

Patient Services

• Digital PSP Platform: End-to-end patient support program management covering enrollment workflows, adherence monitoring, call scheduling, and outcomes tracking.
• Direct to Patient: Home delivery coordination, nursing visit routing, injection training, and self-administration support.
• Patient Enrollment & Onboarding: Digital self-service enrollment with document verification, eligibility checks, insurance validation, and consent management.
• Benefits Verification & Co-pay: Automated insurance benefits investigation, prior authorization tracking, co-pay card management, and financial assistance workflows.
• Call Centre Operations: AI-augmented call centre with real-time compliance monitoring, post-call documentation, and adverse event detection.
• Patient Education & Engagement: Personalized content delivery across SMS, email, app, and WhatsApp, timed to treatment milestones, with engagement tracking.
• Digital Health Campaigns: Disease awareness and therapy initiation support including landing pages, HCP finder, consultation booking, and funnel analytics.
• Nurse Navigator Platform: Coordination for nurse educators covering patient assignment, visit scheduling, documentation, and outcomes reporting.
• Medication Adherence Monitoring: Continuous adherence tracking using refill data, wearables, patient-reported outcomes, and pharmacy claims, with proactive intervention workflows.

Advanced Therapies

• Cell & Gene Therapy Orchestration: End-to-end vein-to-vein coordination covering chain of custody, REMS checks, manufacturing slot management, logistics, infusion, and post-treatment monitoring.
• Apheresis & Collection Management: Collection scheduling, patient preparation protocols, kit logistics, and manufacturing handoff.
• Cold Chain & Logistics Tracking: Real-time IoT-based temperature monitoring with excursion prediction, alerts, and deviation management.
• REMS Compliance Platform: Prescriber certification tracking, patient enrollment, pharmacy qualification, and dispensing controls.
• Treatment Center Coordination: Referral intake, slot management, nursing protocol delivery, and infusion scheduling for treatment centers.
• Post-Treatment Monitoring: Long-term follow-up spanning 15+ years, including adverse event monitoring, outcomes tracking, registry reporting, and protocol compliance.

Commercial Operations

• Digital Ordering Portal: Self-service ordering for clinics with catalog management, inventory sync, delivery tracking, and automated reordering.
• HCP Event Management: Planning and execution of advisory boards, speaker programs, and congresses with built-in compliance and transparency reporting.
• HCP/KOL Engagement: Credentialing, fair market value documentation, aggregate spend monitoring, and conflict of interest management.
• Sample Management (PDMA): Lot-level inventory tracking, distribution controls, lot and expiry management, reconciliation, and PDMA reporting.
• Clinic & HCP Onboarding: Credential verification, agreement management, training, certification, and tier assignment for clinic and HCP partners.
• Field Force Management: Territory management, visit planning, call reporting, and performance analytics for field teams.
• Distributor & Channel Management: Multi-tier distribution management covering distributor onboarding, secondary sales tracking, trade schemes, and redistribution alerts.
• Vaccine Distribution Platform: Cold chain compliance, multi-dose vial tracking, clinic allocation, and wastage monitoring.

Traceability

• End-to-End Serialisation: Serial number generation, encoding validation, aggregation, and commissioning/decommissioning workflows.
• Authentication & Anti-Counterfeiting: Verification scanning, suspicious activity detection, and counterfeit incident management.
• Regulatory Compliance Reporting: Automated reporting for DSCSA, EU FMD, and India DCTS across multiple jurisdictions, with pre-submission validation and exception management.
• Last-Mile Tracking: Distribution-to-patient visibility including delivery confirmation, proof of delivery, returns management, and route optimization.
• Supply Chain Analytics: Demand sensing, inventory optimization, stockout prediction, and channel performance analytics derived from traceability data.
• Government Portal Integration: Automated data exchange with India DCTS, Brazil SNCM, Turkey ITS, and other national portals, including data transformation and submission scheduling.

Compliance

• Compliance Monitoring & Risk: Cross-system surveillance with risk scoring, policy enforcement, exception detection, and auto-remediation.
• Global PSP Compliance: Multi-country compliance management covering consent lifecycle, adverse event detection, and cross-border data governance with country-level configuration.
• Compliance Co-Pilot: AI assistant grounded in organizational SOPs, supporting regulatory Q&A, document scoring, SOP drafting, and policy gap analysis.
• Events Compliance: HCP spend monitoring, Sunshine Act and EFPIA classification, hospitality limit enforcement, and transparency reporting.
• Promotional Review (PRC/MLR): AI-assisted content review covering claims validation, fair balance checks, reference verification, version management, and PRC/MLR workflow management.
• Third-Party Due Diligence: FCPA and anti-bribery risk profiling, sanctions screening, questionnaire management, and ongoing third-party monitoring.
• Clinical Trial Transparency: Registry submissions and results posting to ClinicalTrials.gov and EU CTR, with deadline tracking and cross-registry checks.
• Code of Conduct & Ethics: Whistleblower intake, complaint triage, investigation workflows, anonymous reporting, and compliance culture measurement.
• Compassionate Access: Expanded access management covering request intake, medical review, ethics approval, regulatory filing, and logistics coordination.
• Pharmacovigilance & AE Management: Adverse event lifecycle management including case processing, deadline management, signal detection, and regulatory submission formatting.

Regulatory Affairs

• Submission Pipeline Management: Unified dashboard for tracking all submissions, milestones, and health authority query coordination.
• Dossier Assembly & eCTD: Document organization, ICH module structuring, publishing validation, multi-stakeholder review, and submission package preparation.
• Regulatory Intelligence: Monitoring of guideline changes, regulatory requirement updates, precedent decisions, and portfolio impact assessment.
• Clinical Study Report Drafting: AI-assisted CSR authoring with section drafting, quality review per ICH E3, cross-reference validation, and multi-stakeholder review workflows.
• Labelling Management: Core data sheet management, local label adaptation, artwork coordination, and change impact analysis.
• Variation