The Xcellent Execution
of your clinical trials hinges
on the people involved day to day.
Our monitors are highly trained and have specialized knowledge in clinical trial monitoring procedures.
Pre-Study / Qualification Visit
We initiate a complete assessment of each clinical research site, capabilities of staff 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
We provides full initiation of the clinical research site which includes but is not limited to, trainning review of protocol, regulatory documents, Case Report Form, enrollment requirements, investigational drug and responsibilities for the conduct of the clinical trial.
Interim Clinical Monitoring Visit
To ensure quality, We 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.
Upon completion of the clinical trial, We provides, final retrieval of all data, resolution of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational product accountability and return.