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Biometry

At Med-Clinical, we are committed to supporting you in your strategic development thanks to our skills in biometry.

Biometry activities refer to statistical and data management tasks conducted in the field of clinical research and drug development. This includes activities such as statistical analysis of clinical trial data, designing data management plans, overseeing data collection and quality control, and providing statistical support for regulatory submissions. Biometry plays a crucial role in ensuring the accuracy, reliability, and compliance of data throughout the drug development process.


Data Management Oversight:

  • Monitoring data collection and management processes to ensure accuracy, completeness, and timeliness.
  • Reviewing and approving data management plans, case report forms (CRFs), and database specifications.
  • Providing guidance and support to data management teams on data cleaning, query resolution, and database lock activities.

Statistical Analysis and Reporting:

  • Conducting statistical analyses of clinical trial data using appropriate statistical methods and software.
  • Generating statistical outputs, tables, figures, and listings (TFLs) for inclusion in regulatory submissions, clinical study reports, and publications.
  • Reviewing and validating statistical outputs to ensure accuracy and compliance with regulatory requirements.

Quality Control and Assurance:

  • Performing quality control checks on statistical analyses and data management processes.
  • Reviewing and verifying data accuracy and consistency.
  • Ensuring compliance with Good Clinical Practice (GCP) guidelines, International Conference on Harmonisation (ICH) guidelines, and regulatory requirements.

Regulatory Submissions and Compliance:

  • Providing statistical expertise and support for regulatory submissions, including clinical trial protocols, investigator's brochures, and integrated summaries of safety and efficacy.
  • Responding to regulatory queries and requests for additional information.
  • Ensuring compliance with regulatory requirements throughout the drug development process.