Medicines

ClinSearch has a reputation for providing efficient and affordable clinical research solutions. But besides clinical trials, many other research methods can provide valuable information along the lifetime of a healthcare product. Observational designs, for instance, can document its real-life performance and meta analysis can strengthen a body of knowledge about a drug. ClinSearch teams have a long experience of such investigations. Please see our offer below.

Clinical trials

ClinSearch provides full-service solutions or stand-alone services for Europe-wide phase II-IV clinical trials. These services, further detailed on our medical writing, project management, and biostatistics pages, include:

  • Classical or advanced trial design,
  • Preparation of study documents or electronic materials,
  • Feasibility assessment and pilot studies,
  • Regulatory affairs,
  • Clinical operations,
  • Data management and biostatistics,
  • Medico-economic evaluation,
  • Regulatory medical writing,
  • Scientific communication and publishing,
  • Staffing solutions.

Pharmacoepidemiology

Epidemiological methods represent a precious toolbox for the study of a drug in the context of its actual use. Here are a few common applications of these methods.

  • Cohort studies are an irreplaceable way to document real-life performance and safety of a drug.
  • Case-control studies may be a great help in investigating rare adverse events.
  • Cross-sectional surveys may be used to precise the epidemiology of a condition, for instance to identify the target population of a drug.

Diagnosis and outcome assessment research

Sometimes there is no satisfactory way to characterise a condition or assess the outcome of a health intervention for research purpose. A new measurement tool must then be developed. Our services, in this area, include:

  • Development and validation of questionnaires, scales and indexes,
  • Translation and cultural validation of foreign questionnaires,
  • Diagnosis accuracy studies,
  • Evaluation of screening programs,
  • Clinical decision analysis.

Systematic review and meta analysis

A well conducted systematic review can add substantial value to a body of knowledge about a biopharmaceutical product by generating high level evidence. Such evidence is a valuable material for regulatory purposes or for scientific and medical communication. ClinSearch medical scientists, biostatisticians and writers team up to deliver state-of-the-art systematic reviews for your products.

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Applications

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

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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

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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

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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

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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