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SAFETY AND PHARMACOVIGILANCE



At DiagnoSearch, we understand that patient safety is paramount in a clinical trial and takes the highest precedence. Our Safety Team, comprising of skilled medical and safety experts are available 24/7, 365 days a year for vigilant and thorough Safety Monitoring. Enriched with first-hand knowledge of complex global regulatory requirements, DiagnoSearch offers a vast range of Safety Services across all phases of clinical trials which can be specifically tailored to cater to the partner’s needs:

  • Dedicated and uninterrupted 24/7, 365 days safety desk

  • Development and implementation of a customized Safety Management Plan (SMP)

  • Development of study specific SAE / Adverse Event of Special Interest (AESI)/ Pregnancy Reporting Forms

  • Investigator Team training on Safety Reporting

  • Continued support to sites on safety related queries

  • Setting up and maintenance of Safety Database (Oracle ARGUS /DiagnoSearch Safety Database)

  • Case processing in Safety Database including data entry, primary review and medical review of SAEs

  • SAE assessments including causality assessment, evaluation of expectedness of the event to identify SUSARs and determine requirement of expedited reporting

  • Development of comprehensive SAE narratives

  • Generation and expedited reporting to Regulatory Authorities

  • SAE data review to detect events of similar nature for expedited reporting

  • Identification of safety signals and safety trends

  • Generation of Safety Trackers

  • SAE Reconciliation

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