MDCI provides an entire range of clinical study/trial services to the medical device and IVD industries. Our experienced staff can design a study of appropriate size, prepare all study materials, initiate and monitor study sites, manage the study on a day-to-day basis, create a customized database, enter study data and verify accuracy, furnish periodic study status reports, prepare interim and final statistical reports of clinical findings, and communicate and meet with regulatory agency staff.
We tailor our services to your needs and you will have direct access to senior staff throughout the life of your project.
KEY CLINICAL SERVICES
- Study design/statistical considerations
- Protocol design/writing
- Case report form design/production
- Site evaluation and qualification
- Trial initiation and routine monitoring
- Study management and coordination
- Database development/management
- Data entry and quality control
- Biostatistical consultation and data analysis
- SAS programming
- Periodic study status reports
- Interim and final reporting
- Ancillary services
|
|
|
