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PPCE has over a decades expertise in auditing and quality assurance activities.
The quality challenge
The ongoing challenge in managing the quality of clinical data is to continually monitor data collection procedures and data management practices at every level of the study. This may include:
- Ensuring that data generated during the study reflect what is specified in the protocol (case report form [CRF] versus protocol)
- Comparing data in the CRF and data collected in source documents for accuracy (CRF versus source documents)
- Ensuring that the data analyzed are the data recorded in the CRF (database versus CRF)
- All aspects of the data management processes are compliant with SOPs and GCPs
- Computer systems validation
- Managing the quality of clinical data is a critical job. Companies have neither the spare time nor the spare resources to conduct internal audits on a regular basis. Auditing requires skills and techniques that will allow an overall picture of the systems effectiveness in order to effectively plug the gaps. Employing PPCE to provide this Quality Assurance service will:
- ensure compliance with the protocol, SOPs, and GCPs
- enable systemic problems to be resolved before the end of the study or before the problem escalates
- help reduce data queries, the industry average = $150 per query
- identify ways to reduce cycle times for various processes
- ensure data integrity throughout the study's course and that the data collected are the data required by the protocol
- ensure the accuracy and consistency of data from entry into the CRF to final datasets reported in the final CSR
- play a critical role in dealing with instances of nonconformity while carrying out clinical trials
- ensure a strong methodology for corrective and preventive action to propel the Continual Improvement process within the organisation.
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