Quality Assurance includes all planned and systematic evaluations necessary to ensure that all quality requirements are fulfilled and that a trial is conducted, the data generated, documented (recorded) and reported in compliance with GCP and regulatory requirements.
At NexusCRO we are committed to building quality into all our processes through implementing and maintaining a documented Quality System encompassing quality control and quality assurance. This Quality System includes effective Standard Operating Procedures (SOPs) and appropriate training of staff to fulfil their role within the organisation. (Clintech) Compliance with the Quality System is verified through independent Quality Assurance and individually tailored audit programmes ensure the submission of high quality data that meets local and global regulatory requirements.
Our Quality Assurance (QA) team has the clinical and technical expertise to ensure that the appropriate quality systems are in place for our client's clinical study, the rights and safety of the subjects have been adequately protected, the validity and integrity of the clinical study.
Our Quality Management Group can assist you in managing your quality management systems, by: (Harrison) :
- Reviewing current structure and policies, processes and documentation
- Establishing a comprehensive and efficient system enabling a consistent quality structure
- Identifying and initiating corrective and preventative actions to continually improve your processes
- Assistance in writing, reviewing, updating and adapting standard operating procedures (SOPs) to your specific needs and minimum requirements
- Training auditors and quality managers
- Preparation of training plans and documentation for training In addition to providing routine internal quality assurance support, our QA team provides auditing services to its clients.
- Pre-Regulatory Inspection GCP Audits/Inspection Readiness
- Clinical Investigator Site Audits
- Database Audit
- Clinical study report Audit
- System/Process Audit
- Protocol, protocol amendment, consent forms, patient/volunteer information leaflet and CRF’s
- GMP/Investigational Product Storage, Distribution & Manufacturing
- GLP/Central or Local Laboratories
- Clinical and Specialty Vendor & Service Provider Audits/Assessments
- IRB Audits
- Trial Master File Audits
- Validation/21 CFR Part 11 Compliance Audits
- Standard Operating Procedure (SOP) Evaluations
NexusCRO offers an audit service for investigator sites as per protocol-specific standard operating procedures, ICH-GCP and other regulatory requirements. In addition, auditing of archives, drug storage and distribution facilities, clinical laboratories, as well as vendors/suppliers to the clinical trial processes are available.
Auditing Services include:
Auditing services in short provide a snapshot of the trial.