Meridian Health Systems, is a privately held, California professional medical corporation specifically devoted in financing, developing and commercializing technologies in emerging healthcare market. Formed in 1996, the company has successfully funded and commercialized a non-invasive vascular testing medical device commonly known as Vasocor™, as well as an Enterprise Healthcare Management Information System commonly known as ICE™.
Also, through its wholly owned subsidiary Meridian Health Systems, Inc., (Florida Corporation) serves as a Global Site Management Organization (GSMO)- an organization that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company or a clinical site.
The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. The scope of Meridian's responsibility is limited to the 'site' and hence the eponymous title. Some (but not all) of our responsibilities include:
<>Contract negotiations-including proposal development and budget negotiations.
<>Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval.
<>Patient Counseling
<>Patient Recruitment
<>Patient Follow-up
<>Informed consent form (ICF) translation into vernacular languages
<>Site initiation and trial close-out operations
<>Trial-related documents archival and maintenance
<>Reporting serious adverse events to the CRO and the IRB/IEC
<>Ensuring protocol compliance
<>Advising & alerting investigators of potential protocol violations
<>Advising & alerting investigators of potential ICH-GCP violations
Mission Statement
Our primary mission is to finance, develop and deploy, integrated technology solutions for providing and administering Healthcare.
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