Clinical Monitoring
Global IQ’s dedicated and knowledgeable clinical monitoring team is comprised of full-time, in-house Clinical Research Associates (CRAs) and we also contract regional CRAs where appropreiate. Our CRAs have diverse backgrounds ranging from nursing to clinical research coordination with experience in an array of therapeutic areas. Global IQ encourages its CRAs to obtain accreditation with the Society of Clinical Research Associates, Inc. (SoCRA) or the Association of Clinical Research Professionals (ACRP).
At Global IQ, we stress the importance
of continuous professional development of our CRAs and maintain this
growth through, ongoing monitor training by
recognized professional organizations (SoCRA, ACRP, etc.)
- Comprehensive in-house GCP guidelines training
- Training on relevant, current industry topics such as AE resolutions and GCP
- Company SOP training to ensure monitoring practice consistency.
Specific services provided to our clients by our clinical monitors include:
Providing standard initiation visits and site training packages
- Monitoring throughout the trial
- 100% source document monitoring
- Providing knowledgeable advice and support to the site
- Ongoing site education to protocol, GCP/ICH, and regulatory guidelines
- Maintaining tracking reports as required
- Maintaining and providing contact reports to document communications between the site and our CRAs
- AE and SAE reporting and monitoring
- Continuous site communication through study-specific newsletters, a secure website, and/or study update conference calls
- Query and query resolution to ensure protocol compliance, accurate data collection, and GCP compliance
- Electronic query resolution through Global IQ’s proprietary Internet Data Entry Management System (IDEMS).
Global IQ realizes that each study brings unique challenges and thus requires a qualified, experienced team that is selected specifically to meet those challenges. Our team strives to develop and maintain an excellent professional relationship with the investigator and the sponsor. This relationship is guided by exceptional communications that include:
- Ongoing availability of all members of the trial team
- Informing the Clinical Project Manager of any study difficulties the site encounters
- Continuously liaising between the sponsor and investigational sites.
Well-rounded communication amongst all team members ensures that the study is run efficiently, compliance is maintained, study needs are met, schedules run smoothly, and high-quality data are produced.