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Experience
Monitoring Services
Management Services
Support Services
Our Sponsors |
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Our Monitoring Services Include:
- Centrally or Regionally Based CRA's
- Emergency Site Cleanup / "Swat Team" Projects
- Site Management
- Pre-study Site Qualification Visits (PSSV)
- Initiation Visits (SIV)
- Interim Monitoring Visits (IMV)
- Close-out Visits
- Query Resolution
- Investigator Meetings
Our
Management Services Include:
- Site Identification and Recruitment
- Multi Vendor Management
- Budget Negotiations
- Status Reports - Tracking
- Quality Assurance
- Regulatory Affairs
Our Support Services Include:
Regulatory Services
Project Oversight / QA
NDA Submission / Manual & Electronic
FDA Liason
Clinical Study Report / Technical Writing
Audit Services
Central and Local Lab Audits Investigator / Sponsor / CRO
Audits System Validation
SOP Consultation
Data Management
CRF Design / Development / Tracking
Database Design and Analysis
Electronic CRF Submission
Automatic Query Generation
Validation
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