Company Service
- Project Management
- - Investigator Identification & Qualification
- - Investigator Grant Administrations
- - Study Document Development
- - Regulatory Management
- - Alliance / Vendor Management or Collaboration
- - Clinical Supplies Management
- - Central Laboratory Liaison
- - CJoint IRB Liaison
- Site Monitoring and Management
- - Qualification, initiation, interim, and close-out site visits
- - Project start-to-finish services
- - Query resolution
- - Quality data verification and collection
- - Ongoing communication with site personnel
- - Thorough oversight of compliance, regulatory, drug /
device management, safety reporting, samples management
- - Training of site personnel
- Regulatory Services
- - Regulatory consultation
- - Clinical trial application
- - Import licensing
- - Translation services
- - Design/translate of ICF
- - Pharmaceutical product registration
- - Role as license holder for sponsors
- - Regulatory education and training
- Complete Organization of Investigator Meetings
- - Investigator notebook preparation
- - Conference planning
- - Training & presentation materials development
- Quality Assurance Audits
- - Investigative sites
- - Sponsor study files
- - Study databases
- - Clinical research organizations
- - Central clinical laboratory
- - Bioanalytical laboratory
- - Standard operating procedures
- Medical Writing and Pharmacovigelence
- - Pre-clinical study summary / clinical study summary
- - Clinical protocol development
- - Clinical study report
- - Safety review of case report form or data listings
- - Safety management planning
- - Clinical protocol safety section development
- - SAE processing
- - Coding review
- - Regulatory reporting (MedWatch, CIOMs)
- - Safety reports to investigators/IRBs