clinical development

Special Services

Pharmacogenetics
An understanding of genetic variation is an important role in understanding inter-individual differences in medication response and toxicity. Genetic variation of drug targets may lead to inter-individual differences in drug action whilst genetic variation in drug metabolizing enzymes may lead to inter-individual differences in drug toxicity. Although still in their infancy, the fields of pharmacogenetics and pharmacogenomics are advancing rapidly and are likely to play an important role in shaping future drug development. Expectations include improved design, more appropriate patient selection and more cost effective execution of future drug development programs.

Retrospectively obtaining DNA from trial participants is likely to prove difficult and costly. If requested, we will ensure that the study design includes provision for obtaining DNA from trial participants with the necessary consent for genetic analysis. This would allow:

  • Analysis of genetic variation in drug target or drug metabolising molecules
  • Exclusion of potential trial participants on the basis of genotype
  • Retrospective analysis of trial data, relating outcome to genotype

South Africa with its diverse population and demographic distribution may offer interesting possibilities for companies interested to acquire this information. Virtus has relationships with companies, which are staffed with highly qualified geneticists.

 


 

 

Clinical Research Special Services
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.



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.



 
 

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