VAERS & SAFETY DATA SIGNAL INTEGRITY

Unlike in the past where not all VAEs were reported, the expediency with COVID-19 will drive physicians and experts to over sensitize the monitoring programs to “not miss anything” this time. The sheer number of reports, updates and case volume with overload the systems with overwhelming and mostly irrelevant data.

  • iSafety has in place an integrated network of safety monitoring programs to ensure an authentic safety signal leads up to investigation by maintaining data integrity for precise safety results.
  • Leveraging our advanced data management and analytics technology, our team of experts rapidly mine through humongous data by continuously tracking events signals and deploying the emerging global trends, updates and evolving pathways from authentic sources for –
    • Better data handling in ensuring highest compliance
    • Safety Integrity and Accelerated time-to-market for trial results and vaccine development

SPECIAL DEMOGRAPHICS ACCESS & DATA

Our priority vaccine site network includes high-quality vaccine-experienced sites across major geographic regions with wide point-source experience across patient demographics, diversity and population, including:

Patient Diversity

  • Infants
  • Adolescent
  • Young Adults
  • Middle Aged Adults
  • Senior Citizens
  • Old Age
  • Pregnant

Demographics Diversity

  • High Income Group
  • Middle Income Group
  • Low Income Group
  • Below Line Group

Population Diversity

  • High Density Urban
  • Low Density Urban
  • High Density Town
  • Low Density Town
  • High Density Rural
  • Low Density Rural

SAFETY TRIAL CONTINUITY

iSafety has created a powerful ecosystem of global experts, source-point site networks, domain expertise and AI driven technology to transform the COVID-19 challenges into a safety future for the world by:

  • Addressing the onsite and remote COVID-19 impact
  • Business continuity through regulatory safety support
  • Empowering centralized information for trend assessments
  • Standardizing risk assessment for safe trials
  • Integrating safety monitoring network for signal data integrity
  • Deploying AI powered analytics for speed, accuracy and results
  • Combining 12+ years of development experience, domain expertise and technology resources to advance vaccine development

We are ready and equipped to assist based on specific
requirements and as the need evolves.

Contact us to learn more about how we can assist and accelerate
your Vaccine Program or Business Continuity needs.