Clinical Evaluation LLC
Ongoing medical oversight and monitoring
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Our services include ongoing oversight and monitoring before and during the course of the study. We have formal training and experience in the application of the Good Clinical Practice/International Committee on Harmonization (GCP/ICH) guidelines, which address the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. However, it is not uncommon for protocols, even those prepared by experienced sponsors, to conflict with these guidelines. Our review can include elements of GCP/ICH such as:
- consistent classification of untoward occurrences and Adverse Events;
- preparation of the Informed Consent (IC) document for IRB submission, or review of a previously written IC;
- review and evaluation of protocol deviations or violations;
- review of the detailed written reports of Serious Adverse Events required by GCP;
- assignment to function as the Sponsor’s designated medical expert(s) to advise on trial-related medical questions or problems;
- review of the classification of test results as Clinically Significant or Not Clinically Significant.