EDC, Data Management and Biostatistics

Through internal resources of qualified statisticians, Biomapas has the clinical data management and statistical expertise to consistently deliver high-quality data that accelerates clinical development process. Involved at every step from study inception to delivery of the Integrated Clinical Statistical Report, our team have an in-depth understanding of data supporting our areas of expertise, allowing us to prepare statistical data for submission on time and within the budget.

Biomapas skilled biostatisticians provide trial design consultation, statistical methodology recommendations, statistical programming and analysis to create a customized approach designed specifically to meet individual project requirements:

  • Protocol and statistical analysis plan development;
  • Comprehensive data analysis plans including sample size determinations and power calculations;
  • Detailed descriptions of statistical methodologies;
  • Interpretation of study results and writing support for the preparation of interim analyses and study reports;
  • Preparation of tables, listings and graphs;
  • Integrated efficacy and safety analysis for regulatory submissions.

Data Management team provides high-quality collection, organization, validation, analysis, and quality control of clinical trial data and utilizes electronic data capture (EDC) to expedite data collection:

  • eCRF design, the set-up and edit check specifications;
  • Data validation;
  • User administration.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

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