Adequate Monitoring of Clinical Trials is imperative in assuring safe subjects, quality data and a well-executed study.  Clinique Research Services, Inc. provides comprehensive site monitoring including the assurance of protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites. Our CRA’s act as a liaison between the site and the study teams.  Monitoring visits are conducted at pre-determined intervals and/or as the study dictates.

 

• Pre-Study / Qualification Visit

Clinique Research Services, Inc. initiates 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

Clinique Research Services, Inc. provides full initiation of the clinical research site which includes but is not limited to, 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, Clinique Research Services, Inc. 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 completion of the clinical trial, Clinique Research Services, Inc. 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.

• Other Services

(available upon request)

Auditing
Protocol Development
Medical Writing
CRF Design
Ethics Committee