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STAR (Site Tracking and Recruitment)
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» Clinical Monitoring
Protocol Design
Regulatory Document Management
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Clinical Trial Management
Clinical Monitoring
The Monitoring Services Department is comprised of experienced, credentialed professionals who ensue clinical trials are conducted in accordance with the protocol, standard operating procedures, Good Clinical Practices and applicable FDA guidelines. ACORN CRO monitors also use their expertise to ensure that internal and external customer requests are completed with the appropriate resources and within acceptable guidelines.
ACORN CRO CRAs focus to ensure patient safety and data integrity by conducting: - Site evaluation, initiation, routine monitoring and close-out visits
- Thorough review of the informed consent process, IRB approvals, AE/SAE reporting, and follow-up along with source verification of all subject data
- Investigational product accountability review
- Site training and site support
- Essential document management, trip report tracking, and co-monitoring visits
- Rapid query resolution
While conducting on-site monitoring visits, the monitors strive to develop a professional working relationship with the site staff and prove to be a great asset in their role as the primary line of contact between the Investigative staff and the CRO. Years of oncology experience aid the monitors in query resolution as well as reviewing Adverse Event reporting. Our monitors understand the constraints facing today's oncology practices and as a result, their professional demeanor is as welcome as the sensitivity and expertise they bring to each research site.
ACORN CRAs receive monthly training to remain current with industry trends and changing regulations.
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