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DRUG SAFETY / PHARMACOVIGILANCE

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DRUG SAFETY / PHARMACOVIGILANCE

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Wizard offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and Drug Safety Officer (DSO)activities. Depending on the contractual obligations, the staff at Wizard may take over a part or the complete responsibility for any medical or safety-related issues.
The medical affairs team is comprised of physicians and pharmacists with many years of medical and pharmacovigilance experience and detailed knowledge in various therapeutic areas. By this we ensure that key requirements within clinical trials are managed in line with regulatory demands. For pharmacovigilance this includes not only the expedited reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR) but also the appropriate handling of Serious Adverse Events (SAE) and Unexpected Adverse Event Information. On demand Wizard can provide 24X7 backup to investigators during conduct of trials.

Wizard offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and Drug Safety Officer (DSO)activities. Depending on the contractual obligations, the staff at Wizard may take over a part or the complete responsibility for any medical or safety-related issues.

The medical affairs team is comprised of physicians and pharmacists with many years of medical and pharmacovigilance experience and detailed knowledge in various therapeutic areas. By this we ensure that key requirements within clinical trials are managed in line with regulatory demands. For pharmacovigilance this includes not only the expedited reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR) but also the appropriate handling of Serious Adverse Events (SAE) and Unexpected Adverse Event Information. On demand Wizard can provide 24X7 backup to investigators during conduct of trials.

DRUG SAFETY / PHARMACOVIGILANCE

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

Drug Safety Process

  1. SAE/AE Initial documentation and reporting
  2. Case Report Characterization
  3. Epidemiologic Perspective for Marketed Product Reports
  4. Safety Data Management
  5. AE and SAE tracking, coding
  6. SAE case processing
  7. MedDRA and WHO-DD coding, medical quality review
  8. AE and SAE causality evaluations
  9. SAE narrative composition
  10. MedWatch (FDA 3500A)
  11. CIOMS I forms
  12. Preparation of Periodic Safety Update Reports (PSURs)

Advert Event Reporting And Regulatory Submissions

  1. Electronic submissions to European authorities
  2. US FDA
  3. Canadian Health Authority
  4. Achieving timeline targets
  5. MHLW- Japanese Health Authority
  6. DCGI- Indian Health Authority
  7. Develop safety database

Safety Management For Pre-Authorization And Post-Marketing Services

  1. Call Center
  2. Triaging
  3. Case intake/Data Entry
  4. Safety narrative writing
  5. Medical coding
  6. Assessment of seriousness, causality, and expectedness
  7. Medical Review
  8. Regulatory reporting
  9. Literature Search
  10. Litigation Cases
  11. Crisis Management
  12. Signal Detection
  13. Risk management
  14. Aggregate Reporting