Audits

ClinSearch performs internal and external audits (vendors and partners) for your clinical evaluations and post-marketing surveys under the responsibility of our Regulatory Affairs/Quality Systems Manager.

Our services include:

  • Study documents audits (study protocol, CRF…),
  • Trial Master File (TMF) Audits,
  • Investigator Site File audits,
  • Database Audits,
  • Clinical Study Report Audits,
  • System Audits (Quality Management Systems, Data management, SOP compliance).

Our standards are based on:

  • ICH — Good Clinical Practice,
  • GHTF and AHWP guidance,
  • Good epidemiological practice,
  • Application of regulatory requirements,
  • ISO 9001:2008,
  • ISO 9011:2002,
  • ISO 14155:2011,
  • ISO 13485:2003,
  • ISO 14971:2007.

All audits are performed to assess the quality of study data and conduct, and ensure compliance with our above-detailed standards. These standards correspond to your study’s type (clinical trial or epidemiological study, assessing a drug or a medical device, etc…) as well as appropriate Standard Operating Procedures (SOPs) and the study protocol. According to your company’s preference, either ClinSearch’s Standard Operating Procedures (SOPs) or yours can be used.

Please see also our Quality Policy.

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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