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.
For a full overview of expanded access regulatory frameworks across the US and EU, including when sponsors should offer it and how approval pathways differ, see our guide to expanded access programs.
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.
The built-in audit trails and documentation automation that enabled TGA compliance here are part of Zelthy's broader compliance and quality platform, which extends to pharmacovigilance, SOP management, and continuous monitoring. - 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.
