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Medical Affairs

We are working to build the evidence needed to bring safe and effective diagnostic innovations to health professionals and communities worldwide.

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.

New diagnostic tools and strategies are needed to address current gaps in disease management and surveillance. In a rapidly evolving global health and diagnostic landscape, only people-centred solutions supported by reliable, independent evidence can make a difference.

Sergio Carmona

Chief Medical Officer

Discover our programmes

Our programmes are structured to deliver on our goals in support of universal health coverage and global health security.

Learn more about our clinical trials

We are working to enable high-quality human subject research and strengthen clinical research capacity in low- and middle-income countries.

Explore our biobank services

Available to academic, non-profit, independent, and commercial users, we are working to streamline the development of diagnostic tools by improving the quality, visibility, and availability of sample collections.