CLINICAL RESEARCH

CLINICAL OPERATIONS

We conduct on-site monitoring visits throughout the study to:

• Undertake site management
• Oversee data collection, manage monitoring plans, timing and logistics
• Review source documentation and Case Report Forms
• Manage Adverse Event reporting
• Perform Source Data Validation
• Therapeutic units / study devices management
• Ensure Regulatory Compliance
• Resolve data queries

And also:

• Conduct investigator pre-study meeting
• Training of site study team
• Assist the co-ordination of investigator meeting
• Conduct study initiation site visits
• Undertake study closure visits

We provide support:

• On investigators on site
• In pre-screening of patients
• In eCRF filling

With project management experiences:

• We serve as a primary resource and point of communication for the client and project team
• We provide leadership and direction to the project team, including specifications for time, quality and cost of deliverables
• We use capabilities, systems and processes to assure efficiency and accuracy throughout the project
• We create a management framework to optimize the skills of functional leads, and drives focus on the quality and efficiency of individual tasks
• We follow global risk management process, addressing potential obstacles to project delivery
• We maintain a flexible, can-do approach to address issues innovatively and proactively