Clinical Trial Management Services for Medical Device
MakroCare offers clinical trial management services for new device IDE (Investigational Device Exemptions) studies in different therapeutic areas. These include feasibility/pilot studies as well as pivotal device studies. The key therapeutic area that MakroCare has experience in managing these studies, are orthopedic, cardiovascular,ophthalmic, gastroenterology, diabetes care and diagnostics devices.
MakroCare’s well experienced clinical study management experts’ support device companies to design and run all type of clinical studies, from first-in-man procedures through multi-center randomized global IDE studies.
MakroCare offers end to end services which include:
- Study design to demonstrate proof of principle for first in man studies or pivotal studies
- Operational planning- protocol, CRF/Forms design, site selection, IRB/EC and regulatory notification, site contracts
- Monitoring to ensure compliance to study plan as per IRB and regulatory requirements.
- Ensuring patient safety and timely quality data collection
- Combination of on-site, remote/ central & risk based monitoring, safety monitoring to build efficiencies in the operations
- Paper CRF /mEDC, data management, statistical analysis and study report writing
Apart from end to end services, MakroCare also offers one or more study specific supporting services for clinical trial management to fit into device manufactuers’ 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 finalizations|
|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|
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.