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Drug Safety / Pharmacovigilance

  • Data Collection & maintenance of global safety data
  • Safety medical monitoring of clinical trials
  • Protocol waiver and compliance assessment
  • Serious adverse events (SAEs) surveillance (24-hour coverage)
  • Serious adverse event processing
  • Lab data, imaging data, EKG and QTc, safety review
  • Medical coding of the cases
  • Medical review of the cases
  • Medical /QA review
  • Drug Safety Monitoring Board (DSMB) management. Endpoint adjudication
  • Write DSMB charters and lead DSMBs meetings
  • Drug Safety / Pharmacovigilance operation planning and management
  • Signal Detection
  • Risk Management

 

Drug Safety Process

 

  • SAE/AE Initial documentation and reporting
  • Case Report Characterization
  • Epidemiologic Perspective for Marketed Product Reports
  • Safety Data Management
  • AE and SAE tracking, coding
  • SAE case processing
  • MedDRA and WHO-DD coding, medical quality review
  • AE and SAE causality evaluations
  • SAE narrative composition
  • MedWatch (FDA 3500A)
  • CIOMS I forms
  • Preparation of Periodic Safety Update Reports (PSURs)

 

Adverse Event Reporting and Regulatory Submission

 

  • Electronic submissions to European authorities
  • US FDA
  • Canadian Health Authority
  • MHLW- Japanese Health Authority
  • DCGI- Indian Health Authority
  • Develop safety database

 

Adverse Event Reporting and Regulatory Submission

 

  • Literature review
  • Enhance risk management programs
  • Physician medical review and signal detection
  • Pertinent literature reviews and summaries
  • Post-marketing signaling
  • Pharmacoepidemiology
  • Pre-registration signaling
  • Post-marketing signal assessments; label revision, post-marketing safety studies and design and conduct the registries and clinical trials
  • Literature-based drug class perspective evaluation

 

Safety Management for Pre-Authorization and Post-Marketing Services

 

  • Call Center
  • Triaging
  • Case intake/Data Entry
  • Safety narrative writing
  • Medical coding
  • Assessment of seriousness, causality, and expectedness
  • Medical Review
  • Regulatory reporting
  • Literature Search
  • Litigation Cases
  • Crisis Management
  • Signal Detection
  • Risk management
  • Aggregate Reporting

 

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