Services

Monitoring

GRS provides clinical monitoring at investigational sites around the world to ensure site compliance, timely completion of CRF pages and proper conduct of protocols and subject enrollment. We target our monitoring by implementing a combination of prospective statistical review and focused on-site monitoring enhanced by remote data monitoring through our Oracle Clinical Data Management platform.

GRS through its affiliation with the Association of Clinical Research Organizations (ACRO) has participated in the FDA's Critical Path Initiative related to the development of standards for monitoring. Our goal is to continually develop and implement the most efficient clinical development processes to decrease timelines, increase data quality and ensure effective study conduct. Our CRAs are trained, experienced and regionally based to monitor sites around the world and we employ innovative strategies such as targeted monitoring to maximize the value to our sponsors. Our monitoring services include:

• Pre-study qualification visits
• Study initiation visits
• Study Interim monitoring visits
• Site close out visits
• Source document review
• Regulatory document review
• Product accountability
• Report generation
• Prospective statistical review of monitoring data