"TONUS-LES" CONTRACT RESEARCH SERVICES
"TONUS-LES" LLC

CONTRACT RESEARCH SERVICES 

CLINICAL TRIAL MANAGEMENT & MONITORING 

• Services: Site Identification & Assessment
• Services: Ethics Committee & Regulatory Authority Submissions
• Services: Clinical Study Documents Translation
• Services: Local Insurance Assistance
• Services: Training of Investigators & Their Teams
• Services: Oversight of the Clinical Trial
• Services: File Compilation, Review & Maintenance
• Services: Support for Site Audits & Inspections

SITE MANAGEMENT

• Services: Setting Up Agreements
• Services: Database Review & Identification of Patients
• Services: Pre-screening & Screening Activities
• Services: CRF Completion & Query Management

PHARMACOVIGILANCE & CLINICAL DRUG SAFETY MANAGEMENT 

• Services: Safety Management Planning
• Services: Adverse Event Handling
• Services: Development of Clinical Safety Documents
• Services: SAE Reporting Management
• Services: Safety Reporting to Regulatory Authorities of RA / Ethics Committee
• Services: Local Literature Monitoring

MEDICAL WRITING 

• Services: Case Report Forms (CRFs)
• Services: Clinical Study Reports
• Services: Investigator Brochures (IBs)

REGULATORY AFFAIRS SERVICES 

• Services: Pre Submission Assessment & Consulting
• Services: CTD Format Dossier Preparation
• Services: Regulatory Submissions
• Services: Preparation of Documentation According to National Requirements

LOGISTICS

• Services: Import
• Services: Customs Clearance & Approvals
• Services: Storage, Inventory
• Services: Distribution & Tracking
• Services: Returns & Destruction Management

Did you find an error? Notify us, help us improve our services.

The information entered at 23-08-2014 թ.

The information updated at 13-02-2024 թ.