Services

- Clinical Site Management
- Project Management
- Regulatory
- Biostatistics
- Study Start Up and Feasibility

- Monitoring Services
- CRAs / Lead CRAs
- QC Visits
- Co-Monitoring Visits
- Rescue/SWAT Teams
- Risk Base Monitoring
- Remote Monitoring
- Site Selection
- Initiation Visits
- Study Maintenance
- Close-Out Visits

- Medical Writing Services
- Protocol Writing
- Study Reference Manual (SRM)
- Clinical Monitoring Plan (CMP)
- Clinical Study Reports
- Publications and Manuscripts
- IND Preparation
- NDA Section Writing

- Safety/Pharmacovigilance
- Safety Management Setup
- AE / SAE Case Processing
- Safety Narrative Writing
- Safety Report Submissions

- Auditing Services
- Audit Sponsors, CRO’s and Vendors
- Compliance Audits
- Project Audits

- Training
- ICH/GCP Training
- SOP Development and Training
Employment Opportunities Available
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