compliance and regulatory
Digitizing Compassionate Access Programs with Zelthy
Zelthy’s digital platform cut compassionate access approval times by 65%, lowered costs 40%, and made therapy access seamless and compliant in Australia.
Summary
A leading Australian pharma company partnered with Zelthy to digitize its Compassionate Access Program (CAP). By replacing manual, paper-based workflows with a unified digital platform, the company:
Cut approval times by 65% (from 7–10 days to 2–3 days)
Reduced operational costs by 40%
Achieved a 99% compliance rate with automated audit trails
Improved real-time visibility for doctors, patients, and pharma teams
Strengthened supply chain forecasting and reduced medication shortages
This transformation enabled the company to deliver critical therapies faster, more transparently, and more efficiently, reinforcing its commitment to healthcare accessibility.
Discover how Zelthy's digital platform reduced approval times by 65% and operational costs by 40% for an Australian pharma's Compassionate Access Program.
Overview
A leading pharmaceutical company in Australia partnered with Zelthy to build a Compassionate Access Program (CAP) platform, enabling seamless coordination between doctors, patients, pharma teams, and logistics partners. The platform digitized the entire workflow—from request initiation to medication delivery, significantly reducing approval timelines, increasing compliance, and improving patient access.
With Zelthy’s low-code, highly configurable architecture, the company successfully streamlined manual, paper-based workflows into a single, compliant, digital platform, leading to a 65% reduction in approval time and 40% lower operational costs.
By adopting Zelthy, the pharmaceutical company modernized its Compassionate Access Program, making it faster, more transparent, and highly efficient. The platform provided a seamless, compliant, and patient-centric experience, reinforcing the company’s commitment to improving healthcare accessibility.
With Zelthy’s configurable and scalable healthcare infrastructure, pharma companies can rapidly deploy innovative solutions for patient support, ensuring critical therapies reach those in need—without delays or inefficiencies.
Challenges
The pharma company’s Compassionate Access Program was previously managed through manual, paper-based workflows, leading to:
- Long Approval Timelines: Doctor-initiated requests required multiple emails and manual verifications, often causing delays of 7–10 days before medication dispatch.
- Regulatory & Compliance Risks: Maintaining audit trails and ensuring proper documentation required extensive manual effort.
- Lack of Real-Time Visibility: Pharma teams struggled with tracking request statuses and forecasting supply requirements.
- High Operational Costs: Administrative overheads were 40% higher due to manual data entry, follow-ups, and reporting challenges.
The company needed a secure, compliant, and scalable platform that could automate workflows, provide real-time insights, and enhance patient access.
Solution: A Unified, Digital CAP Platform on Zelthy
The pharma company leveraged Zelthy’s healthcare platform to build a customized Compassionate Access Program solution with:
Role-Based Portals for Seamless Access
- HCP Portal: Doctors could log in, raise requests, upload documents, and track approvals in real time.
- Pharma Approval Workflow: The internal pharma team could review, approve, or reject requests digitally, with built-in compliance tracking.
- Patient & Care Team Access: Patients and caregivers could monitor their request status and receive automated notifications.
- Integrated Logistics Coordination: Approved requests were automatically routed to logistics partners for immediate medication dispatch.
End-to-End Automation & Compliance
- Approval Time Reduced by 65%: Request processing time decreased from 7–10 days to just 2–3 days.
- Regulatory Compliance with Full Audit Trails: Ensured adherence to TGA (Therapeutic Goods Administration) guidelines with automated documentation and real-time tracking.
- Data-Driven Decision Making: Custom dashboards and real-time analytics provided forecasting insights, ensuring optimized inventory management.
- Operational Cost Savings of 40%: Reduction in manual processes and streamlined coordination lowered administrative costs significantly.
Key Outcomes & Impact
- 65% Faster Approvals: Doctors’ requests were processed in an average of 2–3 days instead of 7–10 days.
- 40% Lower Operational Costs: Automation eliminated manual tracking and follow-ups, reducing administrative burden.
- 99% Compliance Rate: Built-in audit trails ensured full regulatory adherence, minimizing risks. Real-Time Tracking & Notifications – Patients and doctors received instant updates, eliminating uncertainty.
- Enhanced Supply Chain Visibility: Pharma teams could forecast demand more accurately, reducing medication shortages.
Conclusion
By adopting Zelthy, the pharmaceutical company modernized its Compassionate Access Program, making it faster, more transparent, and highly efficient. The platform provided a seamless, compliant, and patient-centric experience, reinforcing the company’s commitment to improving healthcare accessibility.
With Zelthy’s configurable and scalable healthcare infrastructure, pharma companies can rapidly deploy innovative solutions for patient support, ensuring critical therapies reach those in need—without delays or inefficiencies.
