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Market Complexities Call for an Integrated Approach to Pharmacovigilance

The complex dynamics of the pharmaceutical market are driving up the expenses associated with maintaining compliant pharmacovigilance activities. As the pharmaceutical industry continues to undergo transformation and expansion, marked by annual increases of more than 20% in reported adverse events (AEs), global outreach, shifting regulatory prerequisites, and the persistence of outdated systems incapable of supporting automation, the burden of costs, quality concerns, and regulatory timelines intensifies.

The need to engage multiple vendors to fulfill all these requirements has created two key challenges for manufacturers:

  1. Vendor Overload – Traditionally, pharmaceutical companies have engaged multiple vendors to introduce new therapies and provide patient support. This approach has proven to be inefficient. Brands need “fit-for-purpose” solutions to address various challenges, whether related to accessibility, promotion, affordability, adherence, or product delivery.
  2. Surmounting Cost, Quality, and Timeline Challenges – In an industry evolving rapidly, characterized by surges in AE reports, global expansion, and evolving regulations that impact operational costs, quality concerns loom large, especially given the stringent timelines that must be adhered to.
  • Vast Industry Experience Experience with top 20 pharma companies
  • Deep Bench of Experts Leadership team with over 20+ years’ experience
  • Reporting Capabilities Direct experience with IND, Annual Report, DSUR, PSUR, Pader Development
  • Integrated Services Dedicated Regulatory group within EVERSANA’s Integrated Compliance Services

EVERSANA Integrated Pharmacovigilance Solution

EVERSANA’s Integrated Pharmacovigilance Solution offers a streamlined, cost-effective approach that ensures full compliance by delivering fully processed adverse event cases. Unlike other solutions in the market that provide automation tools, EVERSANA offers a solution that combines human interaction and AI technology to provide meticulously processed adverse event data that meets all regulatory requirements while significantly reducing your costs per case by 50%. This empowers brands to focus their efforts on what matters most: monitoring the benefit-risk profile and ensuring patient safety.

EVERSANA’s Compliance Services presents a comprehensive suite of services covering the entire product life cycle, encompassing medical information, pharmacovigilance, regulatory, and quality services, eliminating the need to engage multiple vendors. Our services span the entire spectrum of pharmacovigilance, including database management, case processing, reporting, signal detection, literature monitoring, translations, and Qualified Person Responsible for Pharmacovigilance (QPPV) services, providing an all-encompassing, one-stop solution.

We bring a modernized pharmacovigilance model to the table, underpinned by compliance systems, cutting-edge technology, and a team of seasoned healthcare professionals, including MDs, PharmDs, RNs, and RPhs, each with more than two decades of industry expertise. Our end-to-end pharmacovigilance process includes production-ready automation, developed and rigorously tested in collaboration with industry leaders, to ensure the safe and effective use of your product throughout its life cycle.

Our Safety Operations and Pharmacovigilance Services Include:

Case/ICSR Processing

  • Safety Database: Hosted safety databases with client-specific tenancy and electronic records/signature compliant as per 21 CFR Part 11 and Annex Part 11. E2B import and export and electronic gateway capable
  • Post Marketing and Clinical ICSR management: Mailbox set up and monitoring for AE and Safety data. Book-in, Triage, MedDRA coding, data entry, narrative writing, medical review, quality review. SUSAR, AOSE and 15-Day expedited reporting/Submission to Regulatory, Investigators, IRB/EC, etc.
  • Electronic case reporting to relevant regulatory authorities
  • Literature Surveillance and Literature Case Processing: Tailored search that can be applied in global and local databases like Medline, PubMed, and Embase to find safety data and Individual Case Safety Reports (ICSRs)
  • Full understanding of complex devices and combination products regulatory requirements that will allow faster, efficient, and compliant process for such products in safety database for reporting and submission
  • 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

Aggregate Reports

  • Periodic Adverse Drug Experience Report (PADER)
  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Drug Safety Update Report (DSUR)
  • Other reports as required

Signal Identification and Risk Management

  • Comprehensive solution for effective ongoing product safety signal detection, signal identification, evaluation, tracking and monitoring
  • Strategic partnership for all risk minimization activities such as developing risk mitigation or prevention measures. The risk management document such as U.S. Risk Evaluation and Mitigation Strategies (REMS) development and assessments. EU Risk Management Plan (RMP) development.
  • Label management and patient and prescriber communications
  • Drafting responses to regulatory agency and health authority
  • QPPV and LPPV services
  • Audit and Inspection support
  • PSMF, HHR, PLLR, NDA and other such requirements
  • SDEA
  • Support in filing for NDA or any regulatory application

Explore a complete library EVERSANA's Pharmacovigilance resources.

Transforming Drug Safety Automation

Through the integration of technology and automation within a robust regulatory framework, we expedite data processing, facilitating proactive decision-making in product safety. Collaborating with specialists well-versed in market dynamics and regulations not only saves time but also reduces the cost per case by 50%. Our commitment is to uphold regulatory compliance and place patient safety at the forefront through proactive surveillance systems and processes.

Our technology infusion introduces real-time predictive intelligence into our pharmacovigilance services, empowering us to efficiently process and analyze safety data. This capability allows us to confidently predict critical signals and risk factors, pinpoint safety concerns, and offer recommendations for optimizing product utilization to enhance patient outcomes.

Meet EVERSANA’s Experts in Pharmacovigilance.


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