Adequate Monitoring of Clinical Trials is imperative in assuring safe subjects, quality data, and a well-executed study. For each phase of clinical monitoring, GSCC will provide to the client on time a complete, detailed report after each completed clinical monitoring service.

Our GSSC consultants are second to none. All our consultants have a minimum requirement of 5 years of experience in various therapeutic areas in medical device and pharmaceutical clinical trials.

Monitoring Services

Pre-Study / Qualification Visit

GSCC initiates a complete assessment of each clinical research site, staff capabilities and evaluates the site's ability to adhere to FDA regulations, Good Clinical Practices (GCP's), and the overall conduct of clinical trials.

Clinical Monitoring Initiation Visit

GSCC provides full initiation of the clinical research site, which includes but is not limited to, review of the protocol, regulatory documents, Case Report Form, enrollment requirements, the investigational drug, and responsibilities for the conduct of the clinical trial.

Interim Clinical Monitoring Visit

To ensure quality, GSCC conducts ongoing clinical monitoring throughout the conduct of the clinical trial. Activities include informed consent review, eligibility verification, Case Report Form and source documentation review, data retrieval, ongoing maintenance and review of regulatory documents, assessment of protocol adherence, and drug accountability.

Close-Out Visit

Upon completing the clinical trial, GSSC provides final retrieval of all data, resolution of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational drug accountability, and return.