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Quality Assurance

Quality - the Cornerstone of our Services

Quality Assurance is the interface between the Barc Lab's operations teams and the Sponsors that we serve.

Martijn Van Mechelen
Global QA Director

Ensuring Clinical Data Accuracy and Integrity

We are committed to adhering to strict quality assurance guidelines to fulfill your requirement to work under Good Clinical Practices (GCP/GCLP).

A broad range of accreditations and certifications ensure stringent quality management in all aspects of our organization. Consistency and quality are key to our success. As such, processes have been put in place to ensure laboratory results are meticulously monitored with daily instrument calibrations and an extensive internal quality control program.

All of our laboratories (both in-house and partners) participate in a large range of external proficiency testing schemes such as CAP, CLIA, NEQAS, CDC, NGSP and various national and commercial programs. Our Quality Assurance (QA) Department is responsible for issuing and reviewing standard operating procedures (SOPs) and working instructions (WI), performing internal and hosting sponsor audits. Click here for an overview of all accreditations and certifications of our labs.

Client feedback, originating from surveys, audits or complaints, are centralized through our QA department and are used for continuous process improvement. Each finding or complaint is submitted to an in-depth root cause investigation to define appropriate corrective and/or preventive actions (CAPA’s). 

How is GDPR affecting your Clinical Trial?

The European Union (EU) General Data Protection Regulation (GDPR) entered into force on the 25th May 2018 and is the most important change in data privacy regulation over the last 20 years. The GDPR (Regulation (EU) 2016/679) replaces the Data Protection Directive 95/46/EC, and is designed to harmonize data privacy laws across Europe, to protect and empower all EU citizens' data privacy, and to reshape the way organizations across the region approach data privacy. As the new GDPR guidelines aim to strengthen the protection of personal data not only within EU borders, but also considers data from outside EU which is processed within the EU, GDPR is of importance to all companies, regardless of their geographic location.

Martijn Van Mechelen is our Data Protection Officer (DPO) and oversees our Data Protection Strategy and Implementation ensuring compliance with the GDPR requirements.

 

Take a look at our Quality Certifications

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Martijn Van Mechelen

Martijn Van Mechelen, Global Director of QA and DPO

Martijn joined the Cerba HealthCare group as the Global Director Quality Assurance for Barc Lab and Cerba HealthCare Belgium Medical Laboratories in January 2017. Martijn has over 16 years of combined experience within the Pharmaceutical and medical device industry. Martijn is also Barc Lab's Data Protection Officer.