Literature Search Services

Searching medical databases requires creativity and know-how. Our information specialists possess extensive experience conducting searches to support a variety of safety activities
Safety & Risk Management: Literature Search Services

FMD K&L information specialists conduct meticulous searches of medical literature, applying their creativity to optimize search terms and ensure receipt of precise, complete information.

Our literature search services support:
  • Product development programs for pharmaceuticals, biopharmaceuticals & consumer health products
  • Creation of toxicology/safety assessment reports
  • Mitigation of medical malpractice & personal injury lawsuits, including suits involving fetal exposure during pregnancy and misuse/abuse of products
Common literature sources may include:
  • Public & commercial databases
  • Meeting & journal article abstracts
  • Published studies
  • Publications from congresses, conferences & trade shows
  • Literature from registries, studies, regulatory agencies, or drug & poison centers

Medical literature searches for GVP compliance

To help clients comply with Good Pharmacovigilance Practices (GVP) guidelines, we can assist in screening published literature, including:
  • Monitoring of relevant publications worldwide at least once a week
  • Monitoring of all “active substances” for which clients hold marketing authorizations
  • Identifying individual case safety reports (ICSRs) within a journal article
  • Understanding & complying with ICSR timelines
  • Avoiding reporting duplicate ICSRs
  • Describing & analyzing any “new and significant safety findings” from a drug’s periodic safety update report (PSUR) & periodic benefit/risk evaluation report (PBRER)
  • Supporting a product’s risk management plan (RMP) with detailed, systematic searches & assessments
  • Identifying whether a review reveals any indication of suspected change in product safety profile