Pharma-QA provides a range of clinical quality assurance services to its clients, depending on their particular requirements.
Our services are customised to meet the client’s needs.
Sites, Databases, Clinical Study Reports, Documentation
The company has extensive experience in performing these audits in several companies. An audit plan including the scope of the audit is written with the client. Following the audit, an audit report is produced detailing the findings and any recommendations for improving compliance. The audit report is closed once the consultant is satisfied with the resolutions of the required actions.
Through mock inspections, training, advice and on site training
This can be tailored to meet the client’s needs but may include GCP training of in-house staff or investigational site staff including training on the Clinical Trials and GCP directives and related regulations. In addition, SOP training and a full range of up-to-date GCP related issues can be included, if required.
This includes international, corporate, local, departmental and cross-functional Standard Operating Procedures (SOPs), ensuring compliance with the relevant regulations.
Services will be agreed with the client and may include the provision of a temporary QA Manager, supporting the organisation for a period of time.
- Ensure compliance with regulations
- Address audit/inspection findings
- Address system/process issues
- Train staff