FMD provides high quality medical affairs services for late stage development and post market support for drugs and devices.
Our services include:
Post-Marketing Study Design
Post –Marketing Study Site Monitoring
Post marketing studies serve many purposes such as satisfying regulatory requirements and to further investigate treatment risks, benefits and optimal use in real life situations. FMD has vast experience in designing and conducting post approval/ marketing studies, whether you are looking for a CRO partner to conduct a Phase IV interventional clinical trial or a non-interventional observational study.
FMD has conducted many large post-marketing studies for top global pharmas in indications such as oncology, nephrology, CNS, infections disease, hematology, respiratory, cardiovascular and reproductive health.
Post-Market Drug Safety & Medical Monitoring
At Fountain, safety matters! FMD offers safety handling services that are fully compliant with ICH guidelines. Specifically FMD provides adverse event/serious adverse event (AE/SAE) collection, review, assessment and reporting services. In addition FMD also provides DSMB (data safety monitoring board), handling and signal detection service. Safety coding services are handled by clinical staff that are experienced in MedDRA, WHO DRUG and other coding systems.
FMD has rich experience in clinical trials and has cooperated with Health Economic experts in the US and China for Pharmacoeconomic (PE) studies including but not limited to anti-infectious, CNS, family planning products, anti-coagulants, COPD, diabetes, oncology and osteoporosis. FMD provides pricing and reimbursement support service by adopting pharmacoeconomic tools in the China market.
FMD can provide medical writing services both in China and United States. We can provide professional consulting services for trial planning, case report forms, informed consent forms, case studies, investigator’s brochure, and academic papers. Our medical writing team can 1）assist our clients to solve any problems in planning a study, and independently finish the design of clinical study; 2）help with the project management and medical support, communicate with clients and investigators and establish good relationships; 3） help the data and statistic departments with Chinese-English study forms and other documents, and also audit the medical code, Query, SAE and other works.