“I don’t know how you continue to do it again and again, but I will be calling you to save our projects again when my budget is approved."
- Project Management
- Data Capture (EDC)
- Data Management Plan
- ePRO/ECOA/Patient Diaries
- Customized Database Design, Screen Testing & Development
- Edit, Validation and Design Check Programming, UAT
- Double Data Entry, Comparison and Adjudication
- Independent Verification – Data Entry Quality Control
- Data Validation/Data Cleaning
- Query Management
- Local Lab Data Management
- 3rd Party Vendor Reconciliations
- Serious Adverse Event (SAE) Reconciliation
- Global Regulatory and Compliance Certifications: FDA, CFR Part 11, GDPR (EU), ICH GCP HIPAA (U.S.), ISO 27001 and ISO 9001