Biostatistics & Data Management


data management

Data Management Services
  • Paper and EDC trials
  • CRF development
  • Data Management Plan
  • Database design and setup
  • Data migration and mapping
  • Edit checks programming
Advanced Data Solutions
  • MEDDRA and WHO data coding
  • IWRS and customized randomization
  • CDISC standards compliance
  • FDA’s (21) CFR Part 11 compliance
  • Data warehousing
Medical devices investigations

Reviewing clinical study data and ECG traces on a tablet

Biostatistical Services
  • Statistical analysis plan
  • Sample size and power calculation
  • Randomization
  • Interim reports
  • SAS® programming
  • Integrated study reports

Sample Size & Statistical Power


Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present.

Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the probability of rejecting the null hypothesis when the hypothesis is false.

Cinical studies

Laboratory technician operating a centrifuge for sample processing

A critical aspect of clinical trial design is determination of the sample size needed to establish the feasibility of the study. The number of participants should always be:

  • Large enough for precise answers
  • Minimum necessary to achieve aims
  • Ethically justified
  • Statistically powered

For more information about our biostatistics and data management services, please contact us at: info@convex.bg

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From the Research Unit