Data Management

It is obvious that the success of a clinical research in terms of whether the research has reached its objectives or the pharmaceutical product was efficient and safe or not, can be understood with a successful data management and statistical analysis. Therefore importance of estimating right patient population and choosing right statistical analyses methods are highly acknowledged over a decade. Specialized Data Management services of mediSMART are follows as below:

  • Preparation of Data Management Plan
  • Preparation of Statistical Analysis Plan
  • Preparation of Data Validation Plan
  • Sample Size Calculation
  • Database set-up
  • Double data entry and data verification, query generation and tracking
  • medDRA Coding of Adverse Events and Serious Adverse Events
  • WHO Drug Coding of Study Medication
  • Interim and Final Statistical Analyses
  • Preparation of Statistical Analysis Plan
  • Preparation of Clinical Study Report.
Services (All)
mediSMART Medical Research LTD Ekinciler Caddesi Elbistan Sokak Pekiz Plaza No: 5 Kat:B2 34810 KAVACIK BEYKOZ İSTANBUL TURKEY
Tel: +90 (216) 404 10 88 Fax: +90 (216) 404 10 87 ,
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