Wability has proven processes and systems in place for managing reports of Serious Adverse Events (SAEs) or non-serious adverse events in international clinical trials. We offer to process our client’s safety data in their database, or in a customized database at our end, following their SOPs or customized SOPs in a consistent and accurate way. Our clinical trial safety services include:

Triage

  • Assessment of seriousness
  • Data entry according to CRF or SAE report form
  • Extraction and coding
  • Narrative development

Medical Evaluation

  • Verification of medical integrity of narrative
  • Verification of coding
  • Casualty assessment
  • Determination of expectedness

Queries and follow-up

  • Systematic query in case of missing data element
  • Medical query in case of missing medical elements

Quality control (QC)

  • Full data check against source documents
  • Crisis Response and Crisis Management

Wability provides medically qualified staff directly to clients to assist in safety surveillance efforts.Our services include the following:

  • Providing medical reviews and the processing of expedited FDA 3500A and CIOMS I reports.
  • Reviewing legal briefs to identify potential serious events.
  • Addressing incoming telephone calls from health care professionals and consumers.
  • Epidemiological Analysis: The epidemiological components of a surveillance program include:
    • The development of strategies for signal detection.
    • Analysis of external data sources.
    • The creation of registries for continuous safety monitoring of one or more of your products.