Clinical Trial Services

Trial monitoring
Investigator Identification and Site selection
Site Qualification
Site Initiation and Site staff Training
Interim and Routine Monitoring Visits
Ensuring subject safety and regulatory compliance
Source data verification and CRF data review
Monitor Adverse Event reporting
Ensure regulatory compliance
Close Out Visits

Project Management
Project Plan development, Feasibility assessment, Investigator and Site selection
Study set-up and site start up
Organizing Investigator Meetings and Site training
CRA resourcing, mentoring, co-monitoring support and monitoring report review
Third party vendor management
Managing study supplies and clinical site payments
Managing sponsor communications
Ensure the trial team performance is compliant with all applicable regulatory requirements, project-specific SOPs and industry best practices
Managing client expectations for on-time and on-budget performance

Regulatory and medical writing support
Protocol and related document management
Clinical Study Reports (CSRs)
Safety Reports