Clinical Trial Management and Monitoring

At Amarex, management of a clinical trial begins with the identification of a qualified, experienced project manager who serves as your point of contact for all project-related activities. The Amarex project manager works closely with the client to assure that the project is completed on time and within budget.

All Amarex project mangers have a sound background not only in clinical trial monitoring and project management but also in data acquisition, processing, and verification.

Amarex project managers work closely with our clients and the Amarex clinical monitoring, regulatory, data management, and biometrics departments to assure sound clinical conduct and a team-oriented approach.

Before beginning any new project, internal meetings are held to provide study-specific orientation of the entire project team. During these sessions, the therapeutic area, protocol, CRF and study logistics are all reviewed in detail.

The focus of the Amarex project team is to identify potential issues and offer options and solutions to our clients for rectifying and preventing these issues.

Up-front planning and written documentation of plans for site identification and qualification, initial and continuous training for internal and site personnel, study initiation, client and site communications, clinical monitoring, and study closeout provide the process-dependent (rather than
person-dependent) framework under which Amarex standardly operates. Under the direction of the project manager, experienced centrally and regionally located CRAs monitor the progress of your study.

All Amarex CRAs have a B.S., R.N., or related healthcare degree, providing a level of assurance to our clients that these professionals are able to quickly identify and resolve study related issues. Additionally, all Amarex CRAs are
thoroughly trained in ICH/FDA guidelines and GCP and have one or more years of industry experience.

Amarex Study Management and Monitoring Services

• Project Management
• Site Identification and Qualification
• Regulatory Documents Management
• Site Training
• Newsletters
• Site Initiations
• Site Monitoring
• Site Closeout
• Clinical Monitoring Plans
• Protocol Development
• Study Initiation Materials
• Investigator Meeting Planning and Coordination
• Investigator Meeting Presentations
• Contract CRAs
• Safety Monitoring
• Post Marketing Surveillance
• Centralized Enrollment and Randomization Hot Lines and Tracking