Post-Trial Access (PTA) is more than an ethical obligation—it’s a strategic opportunity to demonstrate patient commitment, extend treatment benefit, and strengthen brand equity. Both the World Health Organization (WHO) and the Declaration of Helsinki emphasise that continuous access must be considered during trial design to ensure no patient is left behind once a study concludes.
What Is Post-Trial Access?
PTA refers to the continued provision of treatment to patients who have participated in a clinical trial, especially when the investigational therapy is not yet approved or commercially available in their country.
How Can Pharma Ensure Effective PTA Delivery?
- Open-Label Extension (OLE) Studies
A common approach, OLEs maintain access post-trial but replicate many burdens of the original trial—demanding for patients, investigators, and sponsors alike. They are resource-intensive and often difficult to scale across markets with delayed approvals.
- Managed Access Programmes (MAPs)
A more agile solution, MAPs prioritise treatment over research. They offer ongoing access with a simplified operational framework, including safety monitoring, but without the infrastructure demands of full clinical trials.
Technology: The Critical Enabler of Scalable, Compliant PTA
To meet the demands of global PTA, sponsors need more than a plan—they need the right platform to ensure:
- Seamless Processes
A user-friendly, intuitive digital platform which streamlines the PTA journey for HCPs and patients through automated workflows and configurable logic.
- Risk-Based Safety Monitoring
Integrated, real-time adverse event reporting to meet pharmacovigilance obligations while maintaining compliance with regulatory expectations.
- Centralised Oversight & Transparency
Unified dashboards to provide instant access to patient, country, safety, and usage data—facilitating confident, data-driven decision-making.
Cisv has developed a globally compliant platform for end-to-end Managed Access Program (MAP) management, in use worldwide since 2016. It features integrated pharma and site portals that manage HCP, patient, and order approvals, as well as safety reporting. Optional modules support prospective Real World Data (RWD) capture, eConsent, and ePRO. The system also provides robust reporting tools, access to case books, and comprehensive audit trails to ensure transparency and regulatory compliance.
