clinical development

Site Setup

Site Identification and Recruitment
The success of any clinical trial depends largely on the capability, dedication and experience of the research sites. At Virtus we are conscious of the client's need to reach designated timelines and the importance of selecting and recruiting appropriate investigator sites. Attention is particularly given to site initiation, a site's patient/volunteer recruitment capability, and its ability to collect and record timely data. To assist in these goals we have established a database of investigators who have experience in clinical trial management. Through this we are able to effectively identify dedicated sites, which are well trained and experienced in GCP, and have a good patient/volunteer population. This enables rapid recruitment and timely, accurate data delivery. 

Site Initiation and Training
Virtus conducts a site initiation prior to study commencement and site staff training throughout the clinical program. Topics would include the protocol, regulatory requirements and forms, the scientific background of the disease and drug, toxicity, patient group profiles, concomitant medications, early symptoms of adverse drug reactions, and other areas concerning patient safety.

ICH / GCP regulations are reviewed throughout the trial, via the monitoring process.

 

 

 

Clinical Research Site Setup
Advisory
Virtus offers advisory services for study design and the regulatory processes of South Africa.


Project Management
Virtus ensures that the timelines are closely monitored along with costs and other resources allocated to the project.



Monitoring
Clinical monitoring is conducted through a discrete network of well-qualified and experienced clinical research associates (CRAs).



Quality Assurance
Virtus contracts qualified individuals to conduct independent audits of internal processes as well as external audits of services, processes and systems.



Special services
Virtus also offers various special services.



 
 

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