To outsource your EAP, or not?
If you are a small or mid-sized company… is outsourcing your Expanded Access Program the only way to get treatments to patients in need?
For many, the question of how to administer Expanded Access Programs (EAPs) often leans towards outsourcing. It's a route frequently taken, perhaps because it seems like the sole feasible option. Collaborating with Contract Research Organizations (CROs) and specialized EAP service providers offers invaluable support, encompassing critical services like logistics, adeptness in country-specific regulations, and proficiency in local languages. While these partnerships effectively tackle challenges, they also come with their set of compromises.
CROs and service providers excel in subject matter expertise and operations but tend to lack top-notch technology solutions.
The Value of Maintaining Control
However, there's immense value in maintaining control over your technology platform in-house. Here's why:
Global Accessibility: Software as a Service (SaaS) solutions provide universal accessibility, enabling collaboration among internal and external users worldwide. This significantly expedites decision-making processes.
Enhanced Security: Modern system designs bolster security measures and diminish risks. Permissions ensure appropriate access to information and eliminate the need for sensitive information to be exchanged via email.
Compliance and reduced risk: Approved workflows streamline compliance with in-country regulations, ensuring adherence to standardized processes.
Project Visibility: The ability to see and audit communications and progress ensures you have real-time understanding over the status of your projects.
Control and Adaptability: Full control over processes facilitates rapid modifications, accommodating changes in data capture requirements, expansion into new markets, or the introduction of new programs.
Moreover, opting for in-house technology empowers you with the freedom to choose service providers. This flexibility ensures a smoother transition if you choose to work with new partners, ensuring their alignment with your preferred processes and technology. (Read more about how you can maximize the benefits of partnering for your EAPs.)
Considerations for managing your own technology
Pioneering companies such as Veeva and Medidata have demonstrated that selecting a technology platform does not have to mean service provider exclusivity. CROs and other service providers can use third-party solutions and have even built practices around these solutions to ensure maximum value for sponsors. By choosing your own technology solution, you maintain control and flexibility.
Modern software platforms are now much easier to deploy, configure, and use. Software as a Service (SaaS) models make getting up and running simpler than ever, with low upfront costs thanks to out-of-the-box configurations.
In summary, while outsourcing EAPs via CROs and service providers remains a common choice, the benefits of managing your technology in-house are clear. This approach provides greater control and fosters adaptability and autonomy, enabling companies to respond swiftly to evolving needs while maintaining operational efficiency.