Quality Assurance

Quality in the clinical trial process is essential in order to assure data integrity and subject safety. Although quality is the responsibility of every staff member, TASK has a dedicated Quality Assurance team with the necessary knowledge and expertise to oversee and ensure quality of your clinical research throughout the entire development process.

Knowledgeable  

A QA team with more than 10 years’ experience in GCP across various phases, range of sponsors and many therapeutic areas.

Adaptable

A clinical quality management plan that can be tailor made to your specific needs – whether you need all key indicators to be reviewed 100% or considering a risk based monitoring approach.

Responsible   

Various QA tools were developed and can be utilized to review and report on quality within informed consent, source, protocol  compliance , IP accountability, IP reconciliation and IP compliance, site file administration and subject safety.

Next GCP course dates are:

06 and 07 Feb 2018 (GCP Beginner’s course) and 06 March 2018 (GCP Refresher course)

Cost of courses as follows:

  • GCP Beginner: R3000.00 pp ex vat (ZAR)
  • GCP Refresher: R1800.00 pp ex vat (ZAR)

Please contact:

academy@task.org.za

Services

  • QA of your clinical trial tailored to your needs
  • Training  – TASK Academy offers an accredited two day GCP beginners course presented by the QA team
  • Evaluations & assistance  – whether you have a mature Quality Management System in place or wanting to develop a Quality management  plan or just wondering about your current quality status of your trial, members of the TASK QA team can be outsourced to independently conduct a Quality Assurance Visit at your site to evaluate your current site systems and perform a gap analysis of systems and procedures to be put in to place
  • Audit readiness – an upcoming inspection can be a daunting experience but TASK QA can assist you by reviewing your data and assisting your staff in performing a mock regulatory / GCP inspection

ICH GCP Course For Beginners

Good Clinical Practice is the ethical standard for conducting clinical research. The principles outlined in GCP have a strong focus on subject safety and well-being, and upholding data integrity. TASK Academy offers a two day GCP Beginner’s course where we focus on the local and international standards of Good Clinical Practice. During this course, you are introduced to the following:

  • Where GCP originated from
  • The life cycle of a clinical trial
  • The importance of all role players in clinical research

As an accredited course by the HPCSA, Task Academy aims to provide the opportunity for each research individual to understand clinical research concepts and terms and to build a strong foundation for creating and implementing scientific sound clinical research outcomes.