Ximedica

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  • Your packaging and labeling will meet the new Division of Medical Error Prevention and Analysis (DMEPA) draft guidance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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At Ximedica, our people define who we are.

More About Our People

Lynn Wilson

Lynn Wilson

Clinical & Regulatory Program Manager

Kelly Ashfield

Kelly Ashfield

Director of Quality Services

Stephen Gianelis

Stephen Gianelis

Program Manager

Joni Bouley

Joni Bouley

Business Operations Analyst

Tony Kung

Tony Kung

Program Manager, Hong Kong

Eric Klingensmith

Eric Klingensmith

CNC Specialist