Rationale
A lack of evolution within the pharmaceutical industry’s analytic capabilities has given rise to inefficiency and a failure to leverage modern technologies within the clinical development space. Moreover, the limited regulatory perspective on this matter has become a barrier in implementing and leveraging newer analytical software capabilities.
MoA developed a foundational framework intended to increase Health Authorities’ confidence in the use of modernized statistical analysis and efficient technology across the industry. This framework helps to provide clarity in the use of modern software technologies, including those that generate outputs that support regulatory submissions.
Benefits
- Seeks to enable confident expansion of analytic infrastructure and tools considered valid for use within the regulatory space through increased Health Authority awareness
- Empowers organizations to retain top talent in a workforce that now expects innovative, collaborative, and modern computing environments
- Facilitates more dynamic and modernized analyses to be utilized, potentially allowing faster delivery of innovative products to patients
