Nothing is more important than ensuring subject safety during your clinical trial. Our comprehensive monitoring plans, extensive SOPs, and experienced Clinical Research Associates (CRAs) ensure compliance with domestic and international regulations and guidance. Our CRAs have experience working in the medical industry as RNs, LPNs, or MDs and are proficient in managing the development, coordination, and implementation of clinical operations site management. Each of our CRAs excels in managing, developing, and maintaining clinical trial documents, processes, and systems. Our CRAs will assist you in developing and revising your protocols and protocol amendments, monitoring plans, scope of work, and operations manual.
ClinicalRM’s CRAs work closely with the rest of the clinical team to assure patient safety and data integrity at all times.
Clinical monitoring services include:
• Experienced Staff in the US and Abroad
• Training of Study Personnel
• Monitor Plan Development (Including frequency, intensity, and activity)
• Site Qualification, Initiation, and Close-Out
• Source Document Verification
• Regulatory Document Review and Collection
• Drug Accountability
• Investigational Product Accountability
• Interim Site Monitoring