Services



·Carry out all necessary steps for the ethical and regulatory submission, competent authority (European Regulatory Authority)
·Personal contacts to European Opinion Leaders
·Finding suitable investigational sites and investigators selection.
·Handing all study materials and/or drug issues
·Site and Projekt management
·Phase I-IV (early phase III studies)
·GCP qualität assurance audits


Types of Monitoring Services


·Pre-Study/Qualification Visit
CRC will 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 Praktices (GCP's) and the overall conduct of clinical trials.


·Initiation Visit
CRC provides full inntiation of the clinica research site which includes but is not limited to, review of protocol, regulatory documentsem Case Report Form, enrolment requirements, investigational drug and responsibilities for the conduct of the clinical trial.


·Interim Monitoring Visit
To ensure quality, CRC conducts ongoing 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 regultory documents, assessment of protocol adherence and drug accountability.


·Close-Out Visit
Upon completion of the clinical trial, CRC 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.