Phase IV Studies
We generate evidence...
Having additional safety and effectiveness data is key to supporting regulatory strategies, healthcare system decision-making, and building confidence in new treatments. We design, manage, and execute Phase IV studies that provide real-world evidence, strengthening the market positioning and accessibility of products.
Study Design: We define the best methodology according to the objectives.
Research Center Selection: We identify and coordinate experienced centers aligned with the requirements of each country.
Regulatory Approvals : We manage submissions to health authorities, ensuring regulatory compliance.
Coordination with Researchers : We organize scientific meetings to align and ensure the proper execution of the study.
Data Collection and Analysis: We develop data capture and statistical analysis platforms to obtain validated results.
Reporting and Publication: We present findings in reports, medical conferences, and scientific journal publications.
Access and Regulation Support: We make presentations to support coverage decisions or reinforce positioning.
From study design to results communication, we provide a comprehensive service to generate the necessary evidence to support the growth of your products in the market.