Medical Affairs

Regulators and policy makers rely on high-quality evidence to understand how safe and effective new tests are, and how they address a clinical or medical problem.

Multiple “valleys of death” must be overcome on the road from research and development to uptake, any one of which can prevent them from reaching those who need them. Even when R&D may be progressing smoothly, a fragmented regulatory and policy setting can create obstacles.

To mitigate these risks, our clinical trial and regulatory units proactively assess the policy landscape relevant to target countries, and undertake independent evidence-generation studies. The data collected from these studies serve as evidence to accelerate the development of new diagnostics and to facilitate regulatory approval, policy change and uptake in countries. Building this evidence base is possible thanks to our established multi-country network of clinical trial sites, reflecting the intended settings of use for new tests.