Quality Assurance

What We Provide

Quality of Life Research Center understands the importance of Quality Assurance and the importance of Quality Control for each trial we conduct. Our sponsors, CRO’s regulators and ultimately the patients deserve no less. We have a dedicated QA and QC personal who essentially refers to strategies and policies for ensuring that data integrity, quality, and reliability are maintained at every stage of each clinical trial. 

Our QA personal has established quality requirements and procedures, ensures those procedures are being met and followed along with verifying that the quality of data collection is maintained.

Regarding compliance, our QC personal ensures the quality requirements are being met. It is the ongoing review of data collection of forms and other records for completeness and logic.

Consistence & Reliability

Our Director of Research or her designee conduct weekly research staff trainings to produce consistence and reliability to have all staff on board for adequate data collection and analysis procedures, with a particular focus on remediation that must be done to help assess the validity of data and to carefully document query identification and resolution throughout a clinical trials duration. When necessary, though not often, retraining is held on particularly vexing protocols to continue to follow ICH and GCP regulations.

Site personal conducts:

  • Periodic audits
  • Periodic internal audits of clinical operations
  • Regulatory affairs
  • Safety of subject participation to ensure GCP and safety reporting compliance is met
  • Protocol deviation trends
  • Corrective and Preventative Action (CAPA) effectiveness in reducing critical risks to trial reliability
  • Timeliness of safety reporting
  • Internal GCP audit findings
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