Late Phase studies

MakroCare has extensive experience and expertise in the design and conduct of late phase studies. Due to industry consolidation and globalization, late phase studies are increasingly being conducted as global programs.

Late phase studies can direct future product development and manage risk. Biopharmaceutical and medical device manufacturers have begun to look at the product development lifecycle as a clinical development-commercialization continuum by evaluating risks during product development to proactively plan for risk mitigation activities upon product approval and thereafter. Furthermore, there is increased industry expenditure on approved products to manage safety risks and product utilization, demonstrate effectiveness, and support expanded use through new indications.

Services are comprised of professionals aligned by specific study-segments and disciplines, which include:

• Phase IV
• Post-marketing surveillance
• Observational studies
• Disease and Product registries
• Outcomes research
• Epidemiology