Services
Site Management
Silicon Valley Clinical Research has over 20 years of experience in managing clinical research sites. We can help streamline the process of conducting a trial at your site to integrate with your clinical practice, allowing doctors to prioritize patient care.
We offer:
Protocol Feasibility
Budget Negotiations
Site Set-up
Training
Data Entry
Regulatory Submissions
Regulatory Binder Maintenance
Monitor Visit Assistance
Patient Recruitment
Specimen Processing
Clinical Trial Management
We work with established Pharmaceutical Companies, Device Companies, and Start-Ups across the globe to ensure clinical trials are conducted seamlessly and efficiently. We have experience in managing phase I through phase IV trials in multiple therapeutic areas.
We Offer:
Project Management
Regulatory Submissions
Site Feasibility and Selection
Monitoring
Trial Master File Maintenance
National Clinical Trial Registration
Vendor Selection and Management
Data Management
Our Data Management department is fully compliant for 21 CFR Part 11 and has the capability to deliver extensive clinical data services.
We Offer:
CRF Development and Database Design
Data Management Plan
Verification and Validation
Coding in MedDRA and WHO DD
Query Resolution and Database lock
Design Safety Database
SAE Reconciliation
Electronic Data Integration
Customised Data Listings