Early access programs (EAPs) are initiatives that provide patients with access to investigational therapies before they become commercially available.
These programs, also known as post-trial access or compassionate use programs, allow clinical trial patients to receive continued treatment after the study has ended (Extended Access Programs). EAPs can also help patients that did not participate in the study, but under certain circumstances can receive the investigational therapy until the IMP (Investigational Medicinal Product) receives regulatory approval (Expanded Access Programs).
ADDED VALUES
Data
Management
We can help collect and manage valuable data from Early Access Programs, such as Real World Evidence (RWE) data, which can be used for further research and development or to support regulatory submissions.
Quality
Assurance
We can implement robust quality control processes to ensure that the treatments provided through Early Access Programs meet the highest quality standards.
Global
Reach
We have a global presence and can assist in expanding Early Access Programs to different regions, enhancing the reach and impact of the program.
Real-World
Evidence Generation
Collection and analysis of real-world data post-launch to support further regulatory filings and market positioning. This can include observational studies, patient registries, and other post-marketing surveillance data.
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