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Drug Safety and Pharmacovigilance

We provide integrated pharmacovigilance services to help clients develop and implement safety and surveillance programs for their products. Our experience spans products in early development to marketed products. Our clients include biotechnology firms, large pharmaceutical companies, and generic drug manufacturers.

We are familiar with ICH guidelines for drug safety and pharmacovigilance including the FDA's Good Pharmacovigilance Practices and EMA's European Directive 2001/20/EC guidelines and we develop pharmacovigilance plans that align with the guidelines. We manage and report serious adverse events (SAEs) and adverse events (AEs) either using our clients' proprietary or licensed electronic reporting systems or using our licensed Oracle Argus Safety™, a validated 21 CFR part 11 compliant safety database.

Our services include:

    SAE/AE Handling
  • AE and SAE data entry
  • AE and SAE logging, tracking, coding and case processing
  • MedDRA and WHO-DD coding
    Medical Analysis
  • AE and SAE evaluations
  • SAE narrative writing
  • Physician medical review and signal detection
  • Literature reviews and summaries
    Regulatory Reporting / Medical Writing
  • Generation of MedWatch 3500A/CIOMS I forms and E2B files
  • Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports
  • Preparation of IND Annual Safety Reports and Development Safety Update Reports (DSUR)
  • Investigator's brochures
  • Summary of Clinical Safety (SCS) / Integrated Summary of Safety (ISS) and Summary of Clinical Efficacy (SCE) / Integrated Summary of Efficacy (ISE) reports
  • Preparation of Periodic Benefit-Risk Evaluation Reports (PBRER) / Periodic Safety Update Reports (PSUR) and Periodic Adverse Drug Experience Reports (PADER)
  • Manuscripts

Related Services
Our drug safety and pharmacovigilance services are complemented by several of our other practice areas, including:

 


 
CONTACT US

 
Lynne R Hamm, BSN
Senior Director, Clinical and Medical Services
Carmela A Skillman, PhD
Director, Medical Services

US: +1.800.262.3011
Spain: +34.93.241.7766
UK: +44(0)161.232.3400
For a full list of scientific staff bios, click here.

 
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