CORE SERVICES
We are happy to assist you with any of the following documents :
- Protocol
- PIS & Consent Form
- Investigator Brochure
- Clinical Study Report
- Clinical Evaluation Report
- PMCF Plan
- Abstract & manuscript
- Literature review
Enhance your chance in getting regulatory approvals quickly.
- Submission to EC/IRB & CA
- CTIS completion & submission
- 510(k) notification to FDA
- Public registry registration
- Local activities
- Study notifications
- Annual Reports/ DSUR
Our approach is flexible. We offer:
- Site Qualification
- Site Initiation Visit
- Site Activation
- Monitoring Visits
- Site Metrics Follow up
- PD and Issues follow up
- Close-Out Visits
We prioritize the integrity, quality and security of your study data.
- CRF/eCRF Development
- Data Management Plan
- Data Validation & Edit Checks
- Database Build
- Programming
- Testing
- Data Cleaning
- Query Management
- Medical Coding
- Data Export
- Data Transfer
SUPPLEMENTARY SERVICES
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