Quality Assurance
At RAY, we aspire to provide the highest level of quality to our customers — both in the services we offer and in the processes by which each service is delivered. Our QA policies and standard operating procedures (SOPs) are applied to all activities and systems, focusing on continuous evaluation and improvement, in order to consistently meet our high quality standards.
RAY Clinical Trials team works within a quality management framework. Our procedures are described in a comprehensive set of standard operating procedures (SOPs) which have been written to comply with ICH GCP guidelines, local country regulations, the Code of Federal Regulations and the EU Clinical Trials Directive.
Through our selective hiring processes and continuing professional development training programs, we also ensure that RAY team is among the most talented and highly qualified in the CRO industry.
RAY Clinical Trials team works within a quality management framework. Our procedures are described in a comprehensive set of standard operating procedures (SOPs) which have been written to comply with ICH GCP guidelines, local country regulations, the Code of Federal Regulations and the EU Clinical Trials Directive.
Through our selective hiring processes and continuing professional development training programs, we also ensure that RAY team is among the most talented and highly qualified in the CRO industry.
RAY offers experience in:
- ICH GCP audits.
- Investigator site audits.
- Protocol and Informed Consent Form review.
- Sponsor audits.
- Preparation of investigators for regulatory authority audit.
- Trial Master File and Site Master File Audits.
- Investigational Product storage, handling, dispensing, inventory and destruction.
- Study Documentation handling and archiving procedures.
RAY can also provide you with resources to:
- Develop ICH GCP compliance training programs.
- Develop your SOPs/Guidelines.
- Tailor your global SOPs/Guidelines to local requirements.
- Develop Regulatory compliance training programs.