Case Management

FMD K&L provides the extra hands to manage a large number of cases from a multitude of investigative sites, with careful attention to every detail and thorough application of best practices
Safety & Risk Management: Case Management (Nutritional/Drug/ Medical Device/OTC/Consumer)
We apply proven methodologies and industry-standard best practices through every stage of case management:
  • Indexing
  • Triage
  • Data entry
  • Quality review
  • Medical review
  • Submissions

At each of these stages, FMD K&L professionals pay careful attention to established business metrics and workflow to ensure efficiency, accountability, and transparency. The result is high-quality safety data forming the basis for an accurate profile of your product’s safety.

We offer a comprehensive range of case management services that can be tailored to meet your requirements and/or budget. Select only the services you require, or an end-to-end solution covering your entire development program, from the earliest phases of clinical trials to post-marketing surveillance.

Our services include:
  • Individual case safety report (ICSR) management: triage, case processing, safety review, quality review & medical review
  • Safety literature searches
  • E2B case reporting & archiving
  • Regulatory compliance & tracking
  • Safety data exchange agreement (SDEA) maintenance & tracking
  • Medical information call center (MICC) management
  • Identification of data migration requirements for archiving in a single repository
  • Process optimization: streamline processes & applications by defining inputs, outputs & metrics
  • Automated creation of follow-up letter & narration
  • Submission of serious reports to the regulatory authority
  • Quality assurance