CLINICAL MONITORING AND MANAGEMENT

JANIX has the capacity to cover a broad range of activities paramount to successful clinical research, from small early development Phase I trials to larger global Phase III trials. Beginning with feasibility and extending to study design, protocol, and case report form development, JANIX offers a flexible service menu. A selection of tailored services can be contracted to minimize costs and meet specialized client requirements.

With the ability to service a full array of clinical monitoring and management requirements JANIX offers:

• Clinical Project Management
• Site Recruitment
• ICH/GCP Training of Clinical Staff
• Generation of Study Documents; Protocol, ICF, CRF, SOPs
• Medical Monitoring & Serious Adverse Event Reporting
• Quality Assurance Program
• Conduct Investigator Meetings
• Drug Storage and Shipping Logistics

 All projects are supervised by experienced professionals with proven leadership skills, conducting activities in a transparent manner for informed decision making. High quality project teams are assembled to work interactively and disseminate critical information to sponsors. Governance boards are implemented to ensure sponsor upper management is apprised of project milestones, deliverables, performance metrics, and overall measure of success.

Project Management

• Implementation of resources and clinical study logistics
• Site selection and PI recruitment
• Training for team members and monitors
• Coordinate and conduct weekly team meetings
• Budget overview and interim analysis including detailed reports of actual vs. proposed, etc.
• Coordination of vendor services; IVRS, lab, etc.
• IRB submission
• Organize PI meetings
• Metric reporting on patient enrollment and other important study variables
• Supervision of monitors
• Coordinate with data management teams
• Maintenance and dissemination of trial files and archiving

Providing momentum in the formative stages of a clinical study, JANIX possesses remarkable follow-through to provide the highest quality service with long term objectives in mind.

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