FMD K&L provides medical affairs services for late-stage development and post-market support for drugs and devices
Our global medical affairs team has the experience and capability to provide support for a wide range of post-marketing studies such as:
Post-marketing study design and monitoring
Post-marketing studies serve multiple purposes, such as meeting regulatory requirements and further investigating treatment risks, benefits, and optimal use in real-world situations. FMD K&L has vast experience designing and conducting post-approval/marketing studies and supporting IIT/IIS planning and implementation.
We have supported top global pharmaceutical companies’ post-marketing studies for indications such as oncology, nephrology, CNS, infectious diseases, hematology, respiratory, cardiovascular disease, and reproductive health.
Post-marketing drug safety and medical monitoring
FMD K&L offers safety handling services that are fully compliant with the ICH guidelines. Specifically, we provide adverse event/serious adverse event (AE/SAE) collection, review, assessment and reporting services. In addition, we offer a data safety monitoring board (DSMB) handling and signal detection service. Safety coding services are handled by clinical staff experienced in MedDRA, WHO DRUG, and other coding systems.
FMD K&L has rich experience in clinical trials and has collaborated with health economic experts in the US and China for pharmacoeconomic (PE) studies, including but not limited to anti-infective, CNS, family planning products, anti-coagulants, COPD, diabetes, oncology, and osteoporosis. We provide pricing and reimbursement support service by adopting pharmacoeconomic tools in the China market.