Meet Ka Kei, Senior Risk & Compliance Consultant at CTG in Belgium

My CTG journey started in 2011, almost ten years ago. One of the projects I had been working on at my previous employer was related to Computerized System Validation (CSV) and as this really appealed to me, it was a logical next step for me to start looking for a job in IT where I could use my background in biochemical engineering. I had already worked together with some nice consultants from CTG and I knew that CSV was one of the core businesses of CTG's Regulatory Compliance unit, so my choice was quickly made!

It has been a pleasant journey so far. I really enjoy working as a consultant for CTG: it enables you to work on different projects at various customers. Every project has its own challenges and allows you to learn something new, so you are constantly evolving and expanding your skills and knowledge. Moreover, you can seek advice or help from your CTG colleagues, if you encounter difficulties during your project (or in your private life) or are looking for a sounding board.

In my current project, I am responsible for the validation of an eSource system that is used to manage clinical studies. In this system, all data related to clinical studies is collected electronically, such as scheduled activities of the study, personal data of the volunteer, clinical data (ECG, blood pressure, weight, height, medication dosing date and time…) of the volunteer captured during the study, lab results of volunteer’s sample… Given the high criticality of the data in the system, data reliability, quality, integrity and traceability are of paramount importance in the processing and controlling of the clinical studies. In this project, the team uses the scrum methodology, which was new for me, but I quickly got accustomed to this agile way of working. The eSource system was released a while ago, but new functions and improvements are regularly requested by the client or needed for the execution of a clinical study, which all need to be validated before putting them into production. I am happy to be involved in this project, as this system captures study data of clinical trials that are important for the development of a new drug.

And so my journey continues ...

With our GxP Compliance Services, we support companies in the healthcare and life sciences industries to ensure their products are safe for use. Our services are based on lean, scalable, risk-based, and agile concepts, and follow the latest standards in the market.

Check out https://be.ctg.com/solutions/regulatory-compliance/gxp-compliance-services/ for detailed information.