CLINICAL SAFETY & PHARMACOVIGILANCE

ASSURANCE

The SPV department oversees the overall safety of subjects enrolled in any study in compliance with FDA and ICH regulations (21 CFR). We specialize in the management of clinical trial AE (Adverse Events) and SAE (Serious Adverse Events), including initial AE/SAE receipt, case processing and follow-up, medical review, and case closure. Our SPV experts are also responsible for Medical Monitoring and Medical Coding activities. Our highly experienced clinical safety professionals provide clinical and medical expertise to evaluate the safety and conduct Phase I-IV clinical trials. Their support safeguards the success of a clinical trial through delivery of high quality clinical safety and pharmacovigilance service to the clients.

Services include:

  • 24-Hours/7-Days Serious Adverse Event Reporting

  • Global Drug and Device Related Safety Reporting Activities

  • Safety Management Processes and Procedures

  • Safety Management Plan and Development

  • Manage Safety Reporting Activities (site queries) 

  • Extraction of eCRF Information

  • Submissions of Expedited and Non-Expedited Safety Reports to Regulatory Authorities

  • DSUR (Drug Safety Update Reports) and Periodic Safety Reports

  • Reconciliation of Safety Database with Clinical Database

  • Preparation of Narratives, MedWatch and CIOMS Reports

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