Pharmacovigilance

We Are the Front Line of Protecting Your Product and Your Patients From Risk

Improving the future of drug safety and compliance requires more than just contact centers and reporting adverse events. Realworld success requires an integrated approach to providing value across a products life cycle. We process and analyze safety data to confidently predict key signals and risk factors, identify safety issues and make recommendations for appropriate product utilization that maximizes patient outcomes.  

 

 

Manage the  Unexpected With Proactive Approaches That Result in Timely Reporting

Complex market dynamics are increasing the costs of supporting compliant pharmacovigilance activities. As the industry continues to evolve and expand – greater than 20% per year increases in reported AEs, global expansion, changing regulatory requirements and outdated legacy safety systems – we believe your pharmacovigilance model should, too. Ensure your product is used safely and effectively throughout its life cycle by leveraging our robust compliance systems, cutting-edge technology and operations, and experienced talent.

Our Safety Operations and Pharmacovigilance Services

Case Processing 

  • Post-market pharmacovigilance
  • Clinical trial pharmacovigilance
  • EU pharmacovigilance
  • ICSR case reporting and processing
  • Aggregate reporting (e.g., DSUR, PADERs, PBRERs, etc.)
  • Validated safety databases – ARGUS, ARISg – with company-specific tenancy
  • Literature ADR monitoring

Consulting and Safety Data Science

  • Signal detection and management
    (RWE, FDA FAERS, literature, EURMR, clinical safety, others)
  • REMS and risk management (US/EU)
  • Safety data analysis
  • Global regulatory submissions
  • Regulatory inspection: preparation and support
  • PV operational documents
  • Training
  • PV operations assessments and enhancements

A Strategic Partner

With the right regulatory and strategic guidance, we ensure that you will meet and/or exceed regulatory requirements for safety. Our experienced MDs, PharmDs, RNs and RPhs have more than 20 years of industry knowledge across drugs, biologics, vaccines, medical devices and combination products. Our safety system includes production-ready automation that’s been developed and tested with industry leaders.

Our Comprehensive Safety and Pharmacovigilance Solutions Include:

Clinical Trials Safety

  • Serious adverse event (SAE) case management that includes data entry, safety report narrative writing, coding (SAE terms, concomitant meds, medical history), medical evaluation and quality checks
  • Regulatory reporting and aggregate Development Safety Update Report (DSUR)
  • Safety notifications including Investigator and Ethics Committee (EC) and Institutional Review Board (IRB)

Post-Market Pharmacovigilance

  • Individual case safety report (ICSR) reporting and processing
  • Electronic case reporting to relevant health authorities and aggregate reports –Periodic Adverse Drug Experience Report (PADER) and Periodic Safety Update Report (PSUR)
  • Literature review
  • Electronic Common Technical Document (eCTD) submissions

EU Pharmacovigilance 

  • EudraVigilance certified staff and Qualified Person for Pharmacovigilance (QPPV)
  • Regulatory reporting of individual cases
  • Writing aggregate reports (DSURs, PBRERs)
  • Pharmacovigilance System Master File (PSMF)

Signal Identification and Management

  • Signal monitoring that identifies and evaluates potential signals, signal tracking and monitoring
  • Providing context that evaluates disease backgrounds and event rates, analysis using FDA Adverse Event Reporting System (FAERS) and registries/observational studies safety data review

Regulatory Support

  • Cumulative safety data submissions that cover patient narrative writing for clinical study reports (CSRs) and submission document writing, strategy and submissions
  • Analysis and safety data preparation for data monitoring committees (DMCs) and event review/ adjudication committees, analyses and responding to regulatory inquiries
  • Label management and patient and prescriber communications
  • Response formulation to regulatory agency and competent authority communications

REMs and Risk Management

  • U.S. Risk Evaluation and Mitigation Strategies (REMS) development and assessments
  • EU Risk Management Plan (RMP) development

Validated Safety Databases (ARGUS and ARISg)

  • Hosted safety databases with company-specific tenancy
  • Electronic records/signature compliant: 21 CFR Part 11 and Annex Part 11
  • Clinical and post-marketing AE case management
  • Regulatory reporting
  • E2B import and export and electronic gateway capable

Medical Device Reporting

  • Product Complaint (PC) case management with preliminary determination of reportability, produce complaint documentation and trending of product complaints
  • Case management of medical device reports including medical evaluation
  • Electronic case reporting to relevant health authorities

Discuss how to maximize your product safety with integrated safety operations, pharmacovigilance and risk management services.