Biostatistics and Pharmacovigilance


Biostatistics

Biostatistics is the driving force underlying every clinical trial. Essentially, it's the numbers that will tell your compound's story, demonstrating a drug's efficacy or safety.

Our seasoned biostatisticians apply their deep knowledge of the regulatory environment to help you navigate through the complex areas of study design, sample size, number of studies, analysis methods, data displays and interpretations.

With an understanding of global regulatory requirements and guidelines, and performing statistical analysis accordingly, Izenbio's expertise lies in statistical packages including software like SAS versions 8.2, 9.1.3, 9.2, SPSS and WinNonlin.

SAS Programming

Izenbio has proven experience as a quality Clinical Programming Functional Service Provider to the world's largest pharmaceutical and biotech companies. By following our proven FSP program methods, our clients are able to determine how and where to apply their resources and energies in order to complete their clinical programming efforts on-time at a reduced cost.

Our teams of experienced clinical programmers and statisticians can help you with all of your clinical programming needs including:

Clinical Pharmacovigilance
  • 24 x 7 Call receipt & Triage
  • Processing of SAEs & electronic reporting
  • Causality assessment
  • Clinical Trials Safety Data Management
  • Clinical Study Reports and Annual Reports 
Medical Information
  • Call receipt 24X7
  • Call Management
  • Call routing to appropriate stakeholder
  • Call triaging and information capture in database
  • Management of standard and off label customer inquiries
  • Management of complete cycle from receipt of inquiries to response
  • Capture of inquiries in database
Post-Marketing Pharmacovigilance
  • Data entry into validated electronic database including historic safety data
  • Quality control
  • Medical review, narrative writing, MedDRA coding
  • Reporting: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.)
  • Complete PSUR/PADER generation
  • Literature searches
  • Signal Detection- Benefit Risk Evaluation & Risk Management
Safety Database Consulting
  • Implementation and Validation of Oracle® Argus Safety™ Suite, Oracle® AERS, ARISg, and other commercial off the shelf adverse event reporting systems.
  • E-Submission Gateway Set-up, Pilot Testing with Agencies including FDA and EMEA
  • Requirement specification and system selection.
  • Drug safety and regulatory reporting business processes.
  • Post go live support to address system administration, application administration and business support

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