Human Factors for Pharma:
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- Your packaging and labeling will meet the new Division of Medical Error Prevention and Analysis (DMEPA) draft guidance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