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

cardiac medical devices (EP mapping, RF ablation, Heart Valves, ICD, PM).

Site visits in Belgium, France, Germany, Italy, Netherlands and the UK.


Pharmaceutical Studies

Experienced in local study start-up and monitoring activities (Belgium) in cardiovascular diseases, gastroenterology, rheumatology and infectious diseases.


Activities

Feasibility studies, site selection

Study submissions to Competent Authorities

Study submissions to Ethics Committees


Site Visits:

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.


Close-Out Visit

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.

 
Praktijk voor Kinesitherapie - Acupunctuur - Andullatie - Massagetherapie
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