Ximedica can either assist with or entirely manage all aspects of device clinical trials, under the oversight of our staff Medical Director. We maintain close relationships with regional hospitals. Our team can handle all aspects of pre-study and study execution, data management, and post-study execution. Our capabilities include:

• Preparing the study protocol
• Calculating samples sizes & preparing the statistical analysis plan
• Preparing case report forms and informed consent forms
• Preparing Investigator's Brochure
• Coordinating subject recruitment
• Report of Prior Investigations
• Pre-study site visits
• Investigator Agreements
• Coordination of IRB and EC submissions
• Preparation of monitoring plan
• Monitoring investigative sites and clinical laboratories
• Preparation of randomization scheme
• Preparation of data management plan
• Database design
• Statistical analysis
• Document control on CRFs
• Maintain Adverse Event log
• Close out study
• Prepare sponsor's report
• Execute clinical submissions

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