Managed Access Programmes (MAPs)
What Are Managed Access Programmes?
Managed Access Programmes—also known as Expanded Access, Early Access, Compassionate Use, or Named Patient Programmes—provide a structured, ethical framework for patients to receive investigational or unlicensed therapies outside of clinical trials. These programmes are governed by country-specific regulations and are increasingly recognised as valuable channels for both patient access and evidence generation.
Accelerating Access, Enhancing Evidence
At Cisiv, we empower pharmaceutical and biotech companies to deliver treatment to patients with urgent unmet needs through compliant, efficient, and data-driven Managed Access Programmes (MAPs). Our Baseline Plus platform is purpose-built to support the full lifecycle of MAPs—streamlining access, simplifying workflows, and enabling the collection of real-world data (RWD) to inform regulatory and market access strategies.
AccessNX: The Next Generation Platform for Managed Access
Cisiv’s AccessNx is a validated, flexible, and fully integrated platform designed to meet the unique demands of MAPs:
- End-to-End Workflow Management: From site registration and patient enrolment to drug ordering and safety reporting, our platform supports the entire process with intuitive, role-based workflows.
- Real-World Data Collection: Capture treatment data, adverse events, and patient outcomes to generate insights that support regulatory submissions and health technology assessments (HTAs).
- Regulatory Compliance: Ensure adherence to regulatory requirements, including pharmacovigilance, RWD collection and data privacy standards.
- Rapid Deployment: Our agile setup process enables swift programme initiation, critical for time-sensitive access scenarios.
- User-Friendly Interface: Designed for ease of use by healthcare professionals and patients.
Proven Success in Global Programmes
Our platform has been instrumental in delivering MAPs around the world for over 8 years for multiple pharma companies.
Strategic Integration of Real-World Evidence
With the increasing emphasis on RWD by regulators and HTA bodies, integrating data collection into MAPs is more important than ever. Our platform facilitates the collection of meaningful, high-quality data without overburdening sites or patients, supporting your broader evidence generation strategy. Since its inception we have collected data in over 50 global MAPs.
Partner with Cisiv
Whether you are initiating a single-country programme or a global MAP, Cisiv offers the technology and expertise to support your objectives. Our solutions are tailored to your needs, ensuring efficient programme management and valuable data collection.
