Quality Assuarance

TK-CHAIN® puts togthers a well-experienced Quality Assurance team to ensure that all rules and regulations are being followed. The company monitors the stringent Standard Operating Procedures (SOPs) for every step of the clinical trial. Quality assurance standards  in pharma (Clinical research) as outline in the International Conference on Harmonization – Good Clinical Practice ICH – GCP are followed in all quality assurance processes. The company’s team of experts will keep track of the usage of best practices by team members through regular audits. Furthermore the company will support project sponsors with audit reports at regular intervals for their clinical trial projects worldwide. The sopectrum of services covered includes;

  • Project audits
  • Investigator files / site audits
  • Trial master file audits
  • Database audits
  • Statistical report audits
  • Clinical study report audits
  • Regulatory submission audits
  • Process audits
  • Vendor audits
  • Regulatory guidance and training on GCP
  • Quality metrics for management reporting
  • Investigator meeting support, e.g. presentations on GCP, common audit findings and handling regulatory inspections at sites
  • Regulatory inspection support, e.g. hosting inspections or preparing investigator sites for inspections
  • Standalone auditing service, including investigator brochures, protocols and informed consent forms (and amendments) and regulatory submission documents
Scroll to Top