Clinical Trial Excellence
Comprehensive support for every phase of drug development and clinical program management.
Trial monitoring
Oversee progress and compliance
Investigator Identification and Site selection
Choose qualified sites/investigators
Site Qualification
Assess site capability and readiness
Site Initiation and Site staff Training
Start site, train study staff
Interim and Routine Monitoring Visits
Conduct scheduled trial visits
Ensuring subject safety and regulatory compliance
Protect subjects, meet regulations
Source data verification and CRF data review
Check source vs. case report data
Monitor Adverse Event reporting
Track and report adverse events
Ensure regulatory compliance
Maintain adherence to regulations
Close Out Visits
Final site closure and documentation
Project Management
Coordinate all study activities
Project Plan development, Feasibility assessment, Investigator and Site selection
Plan, assess, and select sites
Study set-up and site start up
Prepare and activate trial sites
Organizing Investigator Meetings and Site training
Conduct meetings and training
CRA resourcing, mentoring, co-monitoring support and monitoring report review
Manage CRAs and review reports
Third party vendor management
Oversee vendor deliverables
Managing study supplies and clinical site payments
Handle supplies and payments
Managing sponsor communications
Liaise with study sponsors
Ensure the trial team performance is compliant with all applicable regulatory requirements, project-specific SOPs and industry best practices
Ensure team follows rules/SOPs
Managing client expectations for on-time and on-budget performance
Meet timelines and budgets
Regulatory and medical writing support
Assist with regulatory/medical docs
Protocol and related document management
Manage trial protocol documents
Clinical Study Reports (CSRs)
Prepare and finalize study reports
Safety Reports
Compile and submit safety updates