Managing clinical outcome assessments (COAs) in all major geographies, we have developed solid relationships with global regulatory agencies and leading professional societies in the field. Our experience lends us an extensive understanding of regulatory processes and guidelines in the U.S. and other markets around the world.
To ensure the swift success of your research projects, we can provide expert guidance on regulatory compliance for every element of your COAs – from design to implementation, to analysis and interpretation.
Our regulatory insights enable more effective strategies for gathering evidence of treatment safety and efficacy, gaining marketing and clinical trial authorizations, and ensuring the success of post-licensing and post-marketing efforts.