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Pharmacovigilance Operations

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  • We offer a cost-effective solution for managing your legacy safety data as well as taking care of your company’s future needs for processing ICSRs.
  • FHS’s ICSR teams receive and triage serious and non-serious AE cases, performing detailed case entry and follow-up, narrative writing, quality reviews and medical review, to enable on-time reporting around the globe.
  • Our experienced pharmacovigilance physicians are involved in reviewing MedDRA coding and in the medical assessment of all cases. We carry out full quality control on each report.
  • We have a specialized submissions team who are qualified users for electronic reporting. Case disposition is tracked and contributes to metrics for regulatory and quality compliance monitoring.
  • We understand the need for keeping to time, for making the right decisions about expedited reporting and for keeping the appropriate people in your company informed If necessary we can tailor our established standard practices to your specific requirements.
  • FHS team searches the literature for reports of adverse events for all types of products, using standard terms, triage analysis, and relevant processing for expedited or periodic reporting
  • FHS operates a comprehensive Pharmacovigilance Literature Screening Service as part of the suite of drug safety services offered by the company.

    • • Features include conduct of searches via validated databases e.g. Medline and Embase,

    • Screening of Abstracts for identification of potential ICSRs and for identification of potential new and significant safety findings for inclusion in aggregate reports,

    • Important non-clinical safety results and ordering selected full publications for evaluation of ICSRs or safety issues.

  • The requirement to proactively screen the published medical and scientific literature as part of a pharmacovigilance system can lead to difficulties: the screening can be time-consuming and resource intensive; inadequate searches are a common finding during regulatory authority inspections; and the identified cases can be complex and difficult to evaluate and to enter onto the safety database.
  • One benefit of contracting FHS to carry out your Literature Screening for you is that we have been offering it as part of our range of drug safety services for several years. Our team has extensive experience in this arena and can comprehensively manage your literature screening requirements in a cost-effective manner. Involving medical review of cases rather than adopting a mechanistic approach can also help to identify important signals in the literature.

  • FHS team has years of experience of writing periodic reports in a cost-effective way. Whether it is a single simple DSUR or PADER or complex PSURs, we can meet the need.
  • FHS ensures that periodic reports, safety summary updates, and risk assessment document are created in the proper format with the appropriate clinical content and are submitted to the relevant regulatory authorities within compliant timelines.
  • FHS provides innovative solutions to write various aggregate reports like;

  • 1. Development Safety Update Report (DSUR) / IND Annual Report
  • 2. Periodic Adverse Drug Experience Report (PADER)
  • 3. Periodic Benefit Risk Evaluation Report (PBRER)
  • 4. Periodic Safety Update Report (PSUR)
  • 5. Annual Safety Report (ASR)
  • 6. Addendum to Clinical Outcomes (ACO)

  • FHS can help our clients determine important identified and potential risks for both detailed and abbreviated risk management plans.
  • FHS team of experts develops US risk evaluation and mitigation strategies (REMS) and REMS update reports; and compiles, writes and updates risk management plans (RMPs) for Europe
  • Signals can indicate the potential for new risks associated with a medicinal product or the potential for the expected risks to have changed.
  • The data which informs the signal detection process can come from a truly diverse range of sources, including but not limited to Spontaneous Reporting System, Clinical Trials pre or post marketing, Pharmacovigilance Literature Screening, Systemic reviews and meta analyses, other forms of active monitoring including risk-benefit monitoring, Periodic Safety Update Reports and Media reports carrying information not channelled through the Spontaneous Reporting system for some reason.
  • FHS performs ongoing signal evaluation and management for clinical and marketed products, including label update analysis and physician review for any identified and potential signals. FHS has access to world-class pharmacovigilance experts who can carry out benefit-risk analysis, advise on strategy and help to effectively communicate the message about new safety concerns both to top levels within your company and any necessary regulatory authorities.
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