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What Services Does GLCC Offer?
Project Management
- Trial design and creation of project plans
- Budgeting
- Study protocol and design
- Adjudication of study endpoints (Clinical Endpoints Committees)
- National and International Regulatory Submissions
- National and International Ethics Committee applications
- Coordination of project staff (internal/external)
- Development and compilation of trail specific documents including
Standard Operating Procedures, manuals and newsletters
- Archiving plans and services
- Event management/Trial status presentations
Site Management
- Investigator and site selection
- Regulatory document collection and review
- In-service training
- Administration of site contracts and payments
- Enrolment strategies
- Site monitoring (national/international)
- Expedited event reporting
- 24hr/7 days clinical hotline
Biostatistics
- Trial design and sample size calculations
- Generation of randomisation tables
- Analysis plans
- Database specifications
- Interim analyses and final reports
Data Management
- Web based e-trials
- Case Report Form development
- Database design
- Forms tracking
- Data entry and validation
- Report generation.
- 24hr/7 days technical helpline
- Quality control/validation
- Document archiving and storage
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