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Clinical Study Management for Medical Devices

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:

  • Study design input/review to demonstrate proof of principle for first in man studies or pivotal studies
  • Clinical study project management
  • Paper CRF/EDC, data management(including data management plan generation, data review, data transfers, etc.), statistical analysis and study report writing
  • Preparation/review of study documentation (i.e. protocol, CRF/Forms design, clinical investigation brochure, IRB/EC and regulatory notification, site contracts, case report forms, patient information, informed consent forms, etc.)
  • Competent Authority and Ethics Committee submission and liaison.
  • Regulatory Compliance management for the study

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 RCT (blinded or unblinded), 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.

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