Safety and risk management

Safety evaluation standards in the medical device world are progressively getting closer to those applicable to biopharmaceutical products. Thanks to its global knowledge and wide experience in clinical evaluation, ClinSearch can bring different services to companies by applying internal procedures in accordance with the European legislation and guidance MEDDEV 2.12/1 rev.6.

These services include:

  • Incident/Serious adverse event (SAE) reporting assistance,
  • Narrative writing,
  • Writing of initial, follow-up and final incident SAE reports,
  • Writing of periodic summary and trend reports.

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Applications

Sample size / continuous outcome Sample size / binary outcome Sample size / time-to-event outcome

News

Morning Read: Non-profit designing free Wi-Fi architecture for hospitals >> Read

Managing retinal vein occlusion >> Read

Let Me Die on the Prairie by Frances Jane Crosby Van Alstyne >> Read

Publication: Volume 16, number 4 (Stevenson). Study found that no conclusive results can be provided on the cost-effectiveness of four non-invasive tests for liver fibrosis [the Enhanced Liver Fibrosis Test, FibroTest and FibroMAX and transient elastography (FibroScan)] in patients suspected of having alcohol-related liver disease. >> Read

Top headlines from HIMSS2012 (Tuesday edition) >> Read

Incidence of diabetic retinopathy in people with type 2 diabetes mellitus attending the Diabetic Retinopathy Screening Service for Wales: retrospective analysis >> Read

Publication: Volume 16, number 3 (Hockenhull). Report finds that whilst some interventions targeted at mental health populations to reduce violence are well supported by the evidence a scattergun approach in the research literature provides little firm evidence for the majority of interventions. Evidence shows small-to-moderate effects for cognitive behavioural therapy for psychological interventions, and larger effects for atypical antipsychotic drugs. >> Read

How the NHS measures up to other health systems >> Read

Publication: Volume 16, number 5 (Ara). Although orlistat, sibutramine and rimonabant are all effective at reducing weight and body mass index and, compared with placebo, are all cost-effective, both sibutramine and rimonabant have been withdrawn because of safety concerns relating to potential treatment-induced fatal adverse events. >> Read

Peter John Fenton >> Read

Publication: Volume 16, number 6 (Reeves). The verteporfin photodynamic therapy cohort study found that treatment and follow-up were much less frequent in routine clinical practice than in research trials and the cost-effectiveness was similar to the highest previous estimate. >> Read

Frederick Valentine Flynn >> Read