In a recent project, a customer developed innovative software designed to address an unmet need in evidence generation. The software had the potential to revolutionize the way data was collected and analyzed, offering new insights and improving decision-making processes in the healthcare industry. However, to bring this groundbreaking software to market, the customer needed to navigate the complex regulatory landscape and gain FDA approval.

The customer faced the challenge of securing FDA approval for its innovative software. This approval was crucial for the software to be recognized and trusted by healthcare providers and stakeholders. The customer sought to leverage the FDA's ISTAND (Innovative Science and Technology Approaches for New Drugs) pilot program, which supports the development of novel Drug Development Tools (DDTs) that fall outside the scope of existing qualification programs. The ISTAND program aims to facilitate the regulatory acceptance of innovative approaches that can enhance drug development and regulatory review processes.

Learn how IQVIA's pioneering approach provided the customer with access to additional FDA support and significantly accelerated the review timelines, enabling a faster path to market.