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Clinical Operations
- Site evaluation and selection
- Site feasibility assessments
- Budget insight
- Contract management
- Site monitoring and management
- Remote site and study monitoring via EDC
- 100% targeted or risk-based monitoring
- Regulatory tasks and related essential documentation management
- Electronic trial master file (eTMF) management
- Management and facilitation of institutional review board (IRB) and/or ethics committee (EC) submissions
- Study and site closeout
Edenwell’s CRAs consistently focus on project delivery that ensures:
- Verification and protection of our human study subjects’ rights and wellbeing
- Accurate, complete, and verifiable source data documentation
- Study conduct follows approved protocol amendments and all applicable regulatory requirements
- Review of clinical monitoring, including risk-based, centralized, remote, and on-site, as well as clinical monitoring reports
- Risk management and document development
- Clinical trials processes including feasibility, site initiation, and study conduct and close-out
- Clinical monitoring activities throughout the study
- Document management
- Data management
- Investigational medical product (IMP) management and drug development process
- Vendor management
- Management of all inspections and audits by Regulatory Agency
Site Management
Edenwell recognizes that the foundation of successful study delivery lies in a precise feasibility assessment, culminating in the careful selection of high-performing sites. Our independent clinical operations group excels in delivering quality site management services, overseeing the complete site lifecycle from initial selection to thorough closeout across every stage of your clinical trial. We take pride in offering flexible options, providing both on-site and remote Source Data Verification (SDV) models. Leveraging our expertise, we tailor our approach to offer the most strategic and efficient site management solutions for your study.
