Human Factors for Pharma:
Good Clinical Practices

Human Factors for Pharma:<br />
Good Clinical Practices

Ximedica's Human Factors processes ensure alignment with companies who hold themselves to Good Clinical Practices (GCP) rigor.

A New Precedent in Human Factors Evaluations

As usability testing requirements become more stringent for manufacturers of drug, biologic and combination products, Ximedica has refined its Human Factors processes to satisfy a higher level of rigor often required by clients expected to meet GCP standards.

What levels of rigor are required by your Human Factors evaluation?

At Ximedica, our processes meet a higher standard, including:

  • Documented procedures for human research studies for HF and usability assessments
  • Policies regarding privacy and scientific misconduct
  • Appropriate controls for protection of health information (data encryption etc.)
  • A supplier qualification program for vendors providing services related to human subject studies (e.g. recruiting, facility rental, data management, etc.)
  • A proceduralized process for inventory and environmental monitoring control of drugs, placebos and biologics
  • Appropriate staff experience level

Understanding the more controls in place, the greater assurance of a positive outcome, conducting a human factors evaluation on your device ensures-

  • Your clinical study is not negatively impacted by use error
  • The efficacy of of training methods, especially for home use, is validated
  • Your packaging and labeling will meet the new Division of Medical Error Prevention and Analysis (DMEPA) draft guidance
  • Medication errors that have the potential to harm patients will be reduced

Ximedica’s Human Factors Engineering andRegulatory teams work in-step to guide you through the planning process to ensure the expectations of both CDRH and CDER are met.

Wherever you are in your process, Ximedica can help

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