Quality Assurance

Provisioning Quality Assurance

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 participants deserve no less. We have dedicated QA and QC personnel who essentially refer to strategies and policies for ensuring that data integrity, quality, and reliability are maintained at every clinical trial stage. 

Our QA personnel have established quality assurance and procedures, ensuring those procedures are being met and followed, along with verifying that the quality of data collection is maintained.

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

Consistency & Reliability

Our Research Director or their appointed representative, regularly organizes training sessions for the research staff. The primary goal is to ensure consistency and reliability in data collection and analysis procedures and to ensure that all staff members are well-equipped to perform their tasks effectively. Special emphasis is given to addressing any remediation needed to assess the validity of data and to meticulously document the identification and resolution of queries throughout the duration of clinical trials. In rare cases, where necessary, retraining sessions are conducted specifically for complex protocols to ensure adherence to ICH and GCP regulations.

Dependable Strategies

Site-based strategies are employed to optimally locate suitable patients, investigators, and research personnel for clinical trials ranging from Phase 1 to 4 across the United States.

We understand it’s critical to have the right patients involved. Our approach ensures the selection of patients whose conditions align with the clinical study’s objectives, enhancing the reliability of the trial results.
Through these comprehensive strategies, we strive to create an optimal environment for conducting successful clinical trials contributing significantly to advancements in medical science.

Site Personel Conduct

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