Using Quality Systems that Produce Solid Data

Clinical Trials and Device Monitoring Services

  • Disease Experience

Oncology, Hematology, Respiratory, Gastroenterology, Diabetes , Cardiology, Central Nervous System disorders, Pain, Osteoporosis, and Alzheimer’s Disease
  • Clinical Trials and Device Monitoring Services

    • On-Site visits (selection, initiation, monitoring, termination, post marketing approval safety monitoring)
    • Phases I-V Clinical Drug Trials 
    • Post- Marketing Safety Surveillance
    • Class II/III Device Trials
    • Risk Based Monitoring
    • e-TMF and CTMS maintenance
    • Centralized remote monitoring and  Site Management
    • Ensure adherence to FDA and ICH-GCP regulations
    • Ensure adherence to local regulations
    • Ensure completion and collection of regulatory documents
    • Teach site staff about their roles and responsibilities in conducting clinical trials
    • Evaluate and report site performance and protocol compliance
    • Perform product accountability and supply tracking
    • Ensure completion and collection of Serious Adverse Events (SAEs)
    • Assist with data validation and query resolution