Slick Slider
MakroCare provides clinical investigation services for new device IDE (Investigational Device Exemptions) studies in different therapeutic areas and full-service PMCF studies. These include feasibility/pilot studies as well as pivotal device studies
Our End-to-End services include:
Apart from end to end services, MakroCare also offers one or more study specific supporting services for clinical trial management to fit into device manufacturers’ strategies. This include:
Study Design | Study Conduct |
---|---|
Medical/clinical expertise to input study design | Project management support |
Clinical hypothesis consultation | Site selection, IRB approval and contract finalization |
Endpoint selection and confirmation | Study monitoring |
Statistical sample size calculation | Simple data capture tool and data analysis |
Protocol/study plan development | Statistical support for analysis |
Protocol writing & CRF designing | Study report writing |
Why Makrocare?
Our team’s expertise covers diverse devices and diagnostic study types, including but not limited to FIM studies, prospective CE Marking and PMCF studies. MakroCare’s innovative approach of integrating relevant services along with its proprietary technology and centralized approach help device companies to achieve cost benefits and efficient study management. Our proven history in managing both domestic and international clinical trials from beginning to end providing strategic assistance for every phase of your clinical trial.