Quality Assurance from Virtus

Quality Assurance is an important and integral part of clinical development. We contract qualified individuals to conduct independent audits of internal processes as well as external audits of services, processes and systems. This ensures adherence to the applicable guidelines or regulations as well as to sponsor requirements. Such audits include:

Clinical trial documentation review and audit
Internal systems and processes audits
Database audits
Investigator site audits
SOP administration system review and development
Laboratories
Consultancy and training for good clinical practices and regulatory authority inspections
Support to all departments to address quality issues

Analie Malherbe (amalherbe@virtusclin.com) is responsible for project quality assurance.

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.

Special services
Virtus also offers various special services.