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Pharmacovigilance

Avoid Unexpected Adverse Events & Changes to Regulatory Reporting Requirements

 

ClinChoice specializes in product safety and risk management solutions for pharmaceuticals, biopharmaceuticals, medical devices, and cosmetics. To limit your exposure to risk, we provide a highly qualified team of experienced physicians and healthcare professionals focused on delivering expert pharmacovigilance, cosmetovigilance, and materiovigilance services.

End-to-End Safety Solutions Covering the Entire Product Lifecycle

  • We intelligently apply the latest technology innovations to extract optimum value from acquired safety data.
  • We address evolving issues related to products and processes evaluating their safety.
  • Our global delivery centers are supported by expert safety professionals familiar with requirements around the world to help develop your products in any region you choose.

 

Risk Management Solutions

Preparation of medical product safety documentation supporting product registration can be a challenging multidisciplinary process. Rely on our safety team to accurately assess risks and develop effective mitigation strategies for pharmaceuticals, biopharmaceuticals, consumer health products, medical devices, and OTC products.
We support applicants and market authorization holders (MAHs) to prepare, collect, and assess the data required to comply with regulatory standards. We then assist in developing risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS) that are fully compliant with current Good Pharmacovigilance Practice (GVP) requirements.

  • Detailed pharmacovigilance plans
  • Risk management strategies
  • Benefit/risk-related services
  • Document writing

 

Our Risk Management Experience

Our drug-safety professionals have the breadth and depth of experience to identify and assess risks and develop effective mitigation strategies. Our healthcare professionals, including pharmacists, PhDs, post-doctorates, and MDs, have 10+ years of experience; team leads have 5+ years of experience, and our practice associates have at least 3–4 years of experience.

  • Analyzing and writing safety information reviews and revisions
  • Overseeing and tracking medical monitoring activities
  • Evaluating risk/benefit
  • Writing all sections of medical assessments
  • Developing and writing full safety profiles
  • Writing risk-related position papers from various databases
  • Developing and writing integrated summaries of safety (ISS)
  • Preparing template-based contents
  • Performing thorough literature searches & assessments of epidemiology
  • Identifying important risks and missing information
  • Reviewing and determining adequate measures for routine and additional risk minimization
  • Generating submission-ready RMPs
  • Checking process assessments to document effectiveness