Adequate monitoring of clinical trials is imperative
in assuring safe subjects, quality data and a well-executed study. For each
phase of clinical monitoring, I will provide to the client in a timely manner,
a complete, detailed report after each completed clinical monitoring service.
Medical Device Studies
Experienced in study start-up and monitoring
activities within Europe on clinical trials in
Site visits in Belgium, France, Germany, Italy,
Netherlands and the UK.
Experienced in local study start-up and monitoring
activities (Belgium) in cardiovascular diseases, gastroenterology, rheumatology
and infectious diseases.
Feasibility studies, site selection
Study submissions to Competent Authorities
Study submissions to Ethics Committees
Pre-Study / Qualification Visit
I initiate a complete assessment of each clinical
research site, capabilities of staff and evaluates the site's ability to adhere
to FDA/EU regulations, Good Clinical Practices (GCP's) and the overall conduct
of clinical trials.
Site Initiation Visit
I provide 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.
Site Monitoring Visit
To ensure quality, I conduct ongoing clinical
monitoring throughout the conduct of the clinical trial as per the sponsor
protocol. Activities include: informed consent review, eligibility
verification, Case Report Form and source documentation review, discrepancy
management, ongoing maintenance and review of regulatory documents, assessment
of protocol adherence, safety reporting, and drug/device accountability.
Upon completion of the clinical trial, I provide final
retrieval of all data, resolution of data clarification queries, assessment of
regulatory documents, review of site regulatory obligations, investigational
drug or device accountability and return.