CORE SERVICES
- Protocol
- PIS & Consent Form
- Investigators' Brochure
- Clinical Study Report
- Clinical Evaluation Report
- PMCF Plan
- Abstract & manuscript
Data Management
- CRF/eCRF Development
- Data Management Plan
- Data Validation & Edit Checks
- Database Build
- Programming
- Testing
- Data Cleaning
- Query Management
- Medical Coding
- Data Export
- Data Transfer
- Site Qualification
- Site Initiation Visit
- Site Activation
- Monitoring Visits
- Site Metrics
- PD & Issues follow-up
- Close-Out Visits
Statistics
- High-end statistical consulting
- Statistical analysis plan
- Randomization
- Submission-ready datasets
- Tables, Listings and Figures (TLFs)
- Statistical reports
- EC & CA submission
- CTIS submission
- 510(k) notification
- Public registration
- Local activities
- Study notifications
- Annual Reports
Safety
- AE Case Processing
- Aggregate AE reports
- Preparation of PSUR
- Annual safety report
- Data Safety Monitoring
- Clinical Events Adjudication
- Medical coding
- Benefit-Risk Analysis
- Literature Surveillance
OTHER SERVICES
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