Clinical Research Monitoring

Clinical Monitoring
Throughout South Africa we have a discrete network of clinical research associates (CRAs) who are well-qualified and experienced with excellent reputations and relationships with the investigators. By being based in the major centres, travel time and expense are kept to a minimum and the CRA's have efficient access to sites for rapid problem and query resolution.

The CRAs:

Are drawn from a variety of medical and scientific backgrounds e.g. pharmacists, nursing staff etc.
They have clinical monitoring experience supported by on-going training

Every effort is made to assign study staff to a project for its entirety, thereby ensuring continuity and consistency in all monitoring activities.

Medical Monitoring
This includes addressing site queries concerning inclusion / exclusion criteria, protocol interpretation, concomitant medications, adverse events and reporting to MCC and the Ethics Review Committees. We have access to Medical Monitoring Services via our relationships with clinicians and medical centres, should these be required by a sponsor.

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

Site setup
Virtus selects and recruits appropriate investigator sites, conducts site initiation, manages patient/volunteer recruitment and ensures site staff training.

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

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.

clinical development

Clinical Monitoring Services