PHARMACOVIGILANCE

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PHARMACOVIGILANCE

At Cispact, our key focus is to ensure patient safety and product quality through our highly customisable and detail-oriented pharmacovigilance services. Our team boasts of experts who support clinical trial and post-marketing safety surveillance across the globe for various pharmaceutical, biotechnology and medical device companies. As well trained and highly qualified experts, the team at Cispact works seamlessly across various therapeutic areas to ensure the successful delivery of pharmacovigilance services to our customers. We adopt the best industry practices in assessing, analysing, and evaluating the safety profile of the products at an exceptional level of quality. Right from pre-marketing to post-marketing pharmacovigilance activities to support services, Cispact justifies every service throughout the entire process.

Planning & Strategy

Pre-Marketing Pharmacovigilance Services

  • Research beyond the business plan

    Case intake, data validation, causality assessment, data entry, medical coding, writing safety narratives, quality reviews, draft reporting, follow-ups, medical reviews, labelling, expedited reporting related to Individual Case Safety Reporting & regulatory submissions.

  • Marketing options and rates

    Authoring and reviewing of Development Safety Update reports (DSUR), providing flexible and customised writing, risk-assessments, management of report developments and coordination of stakeholder contributions.

  • The ability to turnaround consulting

    Reconciling the data management database with the Pharmacovigilance database to ensure data consistence, remove contradictory information & remove duplicity.

  • Help companies into more profitable

    Clinical Study export, import, creation, copying, deleting, versioning, design analysis, configuration settings, mid-study changes, etc.

  • Customer engagement matters

    Documentation of un-blinding procedures/protocols, details of code-break and data analysis/safety monitoring and process for emergency.

post-marketing Pharmacovigilance Services

  • Post Marketing Case Processing and Reporting

    Case intake, data validation, causality assessment, data entry, medical coding, writing safety narratives, quality reviews, draft reporting, follow-ups, medical reviews, labelling, expedited reporting related to Individual Case Safety Reporting & regulatory submissions.

  • Aggregate Reporting (PBRER, PSUR, PADER and ACO)

    Authoring and reviewing of Global Aggregate Reports (DSUR), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum Clinical Overviews (ACOs) and Periodic Adverse Drug Experience Reports with the review of the cumulative safety information from a wide range of sources. Support in developing documents requested from the regulators on Ad-hoc basis such as unscheduled benefit-risk assessment in response to a potential risk for preparing Risk Management Plans.

  • Safety Signal Management

    Identification, evaluation and management of drugs safety signals throughout a product life cycle. Identification of various source data, signal detection, prioritisation, analysis, and assessment with recommendations for safety actions. Leveraging most efficient and effective methods for each product that is compliant with legislative requirements.

  • Risk Management Plans

    Identifying risks, potential risks and missing information, managing them and introducing risk mitigation strategies throughout the clinical development process by complying and maintaining each product’s RMP (Risk Mitigation Plan).

  • Literature Services

    Screening and reviewing of global and local literature with scientific translations accessing the ongoing safety surveillance of the medicinal products and medical devices. Risk analysis of product, risk assessment and signal detection reports. Identifying and documenting the periodic safety reports for regulatory submission.

  • Medical Information Call Centre

    A scalable, secure and compliant round-the-clock medical information call centre providing specialized services in medical information, product complaint handling and adverse event management for the pharmaceutical, biotechnology and medical device companies

OTHER SERVICES


  • Safety Data Migration, Archiving and IT Recovery Systems
  • Quality and Compliance Check
  • Global Safety Database Creation & Validation
  • SOP Development
  • Regulatory Audit & Compliance Support
  • Setting up of end to end PV System
  • EU and local QPPV Services

" We at Cispact consider drug safety the most essential aspect for a successful clinical project/trial and hence assure and abide by the highest quality drugs. "