Quality & Metric Reporting

As a clinical research organization, Veritas CRO adheres to specific procedures for the monitoring and analysis of quality in determining how the service requested by the sponsor is met. VeritasCRO acts in accordance with the Quality Management System (QMS), which is based on the Good Clinical Practice Manual. Each staff member of VeritasCRO controls his/her own tasks as well as the ones performed jointly with other units. The company provides the training needed for the execution of this responsibility. Articles indicating ethical approval, consent of the participants, and source of funding have been associated with greater adherence to reporting guidelines.

Through continuous internal audits and controls, it is ensured that work is done according to rules. Veritas CRO's own web-based e-CRF system VeriFAST increases quality standards to an upper level. It is progressing with the necessary medical support to prepare sets within the system. VeriFAST runs the system by prioritizing the Law on Protection of Personal Data in the whole process.

VeritasCRO has targets to improve quality within the scope of reporting to the sponsor they are in contact with. The organization is considers measuring the performance of the process as well as the performance of the individual. It determines possible actions intended to improve related processes. A single Quality Management System is optimized and utilized for all sponsors. By conducting business planning about the ongoing study, target dates are determined. The plans and dates are shared with the sponsor. Aspects that a staff member needs to improve are clarified by providing a satisfaction survey and other feedback mechanisms for each staff member. By the effective distribution of workload, the staff is included them in Quality management system. In conclusion, by finding ways to manage quality effectively and efficiently, processes are designed to measure quality.

 

References:


1.Jonathan RoweDenise Calaprice-Whitty,  Quality Metrics for Clinical Trials Jul 08, 2015 Applied Clinical Trials

2.Kathie Clark, Produced by TMF Reference Model, 01Aug2017

3.Benjamin J. P et all. Measuring Blood Pressure for Decision Making and Quality Reporting: Where and How Many Measures? Annals of Internal Medicine W-290 21 June 2011 Volume 154 • Number 12

 

 

 

Quality is not something that is dictated, it is something that is felt.

 

John Guaspari