Expert Training & Consulting for Clinical Research
Transforming research with tailored consulting services.
Clinical services include
Quality Services
- GxP Auditing and Consulting Services
- GCP Auditing
- Quality Management System (QMS) Support
- Mock Inspection
- Inspection Readiness
- QA Support
- Training
Clinical Site Monitoring activities include:
- Site Assessments
- Site Initiation Visits
- Closeout Visits
- On-site and Remote Monitoring
- Protocol and Regulatory Compliance
- Site Qualification Visits
- Interim Monitoring Visits
- Risk-Based Monitoring
- Resolution of Data Queries
- Data Collection and Reporting Review
Trial Master File (TMF) Management activities include
- TMF Build and Implementation
- Regulatory Compliance Assessment
- TMF Quality Control
- TMF Closure and Transfer Support
- TMF Organization and indexing