Managed Access Programs (MAPs) provide a crucial pathway for patients with serious or life-threatening conditions to access investigational medicines or therapies that have not yet received marketing authorisation. These programs are designed for patients who cannot participate in ongoing clinical trials and have no other treatment options available. Typically managed internally by pharmaceutical companies, MAPs offer a lifeline to those who have exhausted other approved treatments.
At Commercial Eyes, we specialise in the seamless execution of MAPs on behalf of pharmaceutical companies. We don’t just run these programs—we integrate deeply within our clients’ processes, ensuring that every aspect of the MAP is managed with precision and care. In our experience, we can also recommend improvements to internal systems and ways of working that improve patient outcomes, as well as create more internal value for the company. So, what do we do that is different?
Our comprehensive approach includes:
Patient Enrolment: Streamlining the process to ensure eligible patients are quickly and effectively enrolled.
Regulatory Compliance: Navigating the complex regulatory landscape to ensure all activities meet stringent legal and ethical standards. This has become increasingly important as we educate regional and global teams about the local requirements.
Logistics Coordination: Managing the distribution and delivery of therapies to ensure they reach patients promptly.
Ongoing Support: Providing continuous assistance to patients and healthcare providers throughout the program.
Instead of dedicating valuable Medical Team resources to these activities, clients have found significant benefits in partnering with us to deliver their MAP, focusing on core business. We can demonstrate improved operational efficiency and ensure that the MAP is managed by experts who understand the unique challenges and regulatory requirements of these programs, ultimately leading to a more streamlined, effective and safety-compliant process.
Whether working within a client’s existing MAP system or utilising our proprietary software, we tailor our approach to fit seamlessly with our client’s internal processes and approval workflows.
Case Study: Outsourcing and enhancing efficiencies in Managed Access Programs (MAPs)
Brief:
Our client aimed to outsource their internal MAP (Managed Access Program) processes to improve efficiency and maintain high-quality outcomes. Their existing approach relied heavily on multiple spreadsheets and offline processes, requiring significant manual input to integrate data into their system.
Solution:
Over a structured four-week training program, our dedicated program coordinators seamlessly integrated with the client’s team. They developed a comprehensive framework and platform to manage MAP processes, including managing internal approvals, follow-ups, addressing HCP inquiries, and coordinating with logistics and customer service teams for streamlined execution.
Results:
The creation of a dedicated MAP platform revolutionised the client’s workflow, reducing manual efforts and significantly enhancing efficiency. The transition and continue workflow freed up multiple internal resources, enabling the program to handle hundreds of cases efficiently.