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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.

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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

CLINICAL SAFETY & PHARMACOVIGILANCE

ASSURANCE

MEDICAL MONITORING

  Services include:

  • 24-Hours/7-Days on-call physician

  • Medical Monitoring Plans

  • Risk Management Plans as a part of pre- or post-marketing approval procedures

  • Provide Medical Monitoring support for on-going clinical trials (e.g. assist Principal Investigators with patient eligibility criteria questions, other protocol related questions and review protocol deviations)

  • Medical review of adverse events, labs, vital signs, ECG's and other study related data-sets during signal detection

  • Support Data Management team with the review of case report form and Electronic Data Capture (EDC) system

  • Coding of adverse events, concomitant medications and other study related data and ensure data coding is complete and correct based on MedDRA and WHO-DRUG coding dictionaries

  • Participate in the Data Safety Monitoring Committees (DSMC) from medical monitoring perspective

  • Review study-specific documents such as informed consent forms (ICFs) and investigator's brochures (IB)

  • Provide study-specific therapeutic area training for core team

  • Provide medical input on clinical study reports and assist in writing integrated summary of safety (ISS) reports

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