Siron’s focus on quality and the existence of our internal quality program is available to customers. We offer outsourcing services, as part of which an independent person, our QA/QC officer, will review, report and touch up those aspects of your study that raise your concern.
Our services include:
Clinical Study Document Review
A| full review of your study files to check for completeness and accuracy according to applicable SOPs, guidelines and regulations. Consistency within the clinical trial documents will also be checked.
Accompanied site visits
The objective of the accompanied site visit can be twofold; 1) an independent assessment of the clinical monitor’s performance or 2) the site study team’s performance.
Monitor: Our QA/QC officer will visit the site, together with your clinical monitor, to assess his/her competence in site management, study-related procedures, skills and adherence to procedures.
Site: Your clinical monitor will be accompanied by our QA/QC officer during a routine monitoring visit, where the emphasis is on assessing the site performance. These visits will take place in case of concerns regarding quality, ICH-GCP non- compliance, or following an audit/inspection to ensure that corrective actions have been implemented.
Preparation for Inspection visit
The QA/QC officer will – independently or accompanied by your clinical monitor- perform a 1-2 days site visit. During the visit the site procedures, quality of the source documents, protocol and guidelines compliance, SIS/ICF procedure and documentation, investigational product handling and documentation, and (serious) adverse event documentation will be reviewed. A thorough review of the investigator site file concludes the inspection preparation site visit. Following the visit, issues observed will be summarized and a corrective and preventive action plan will be recommended.