Clinical Trials and Device Monitoring Services

Our experienced staff has over 18 years of hands on clinical research knowledge and expertise in the Pharmaceutical and Biotechnology industry. Our knowledge base includes extensive experience in conducting Pre-Study Visits (PSVs) , Site Initiation Visits (SIVs), On-Site Interim Monitoring Visits (IMVs), and Site Close-Out Visits (COVs).

Our clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our monitoring services include:

  • Conducting site visits (selection, initiation, monitoring, termination)
  • Ensure adherence to FDA and ICH-GCP regulations
  • Ensuring adherence to local regulations
  • Ensuring the completion and collection of regulatory documents
  • Instructing the site staff in their roles and responsibilities in conducting clinical trials
  • Evaluating and reporting site performance and protocol compliance
  • Performing case report form (CRFs) collection
  • Performs product accountability and supply tracking
  • Ensures completion and collection of Serious Adverse Events (SAEs)
  • Assists with data validation and resolution of queries