Our Human Factors and Research Services
Maximize your regulatory and clinical success through our human factors and usability research services. We employ various methods to help you collect and incorporate meaningful patient-engagement data that supports innovation, benefit-risk decisions, and project timelines. We proactively identify usability risks that would cause project delays or costly mitigations.
User Characteristic Research
Understand your user population like never before. Gain cutting-edge insights into your product’s usability needs through our information analytics and user characteristic attribute assessments.
User Characteristic Research Services
Information Sciences / Analytics
Physical, Behavioral, and Psychometric Attribute Measurement
Patient Experience Research
Support your patient-focused product development process through our comprehensive HF-focused patient experience research options. Whether you are looking to gain deeper insights into the patient’s journey, identify treatment burdens and areas of improvement for a clinical study through simulation, or evaluate potential drug delivery devices, we have a human factors focused solution for you.
Patient Experience Research Services
Patient Therapeutic Assessment
- Patient Journey
- Disease Burden
- Therapeutic Burden
- Latent & Blatant Needs Assessments
Exploratory Key Stakeholder Interviews
- Physicians/Prescribers
- Family Members/Carers
- HCPs
- Purchasing
Drug Delivery Device(s) Assessment
Clinical Study Design Assessment
Technical / Regulatory Analysis & Documentation
Ensure your medical product documentation needs are met with our HF assessments and usability documentation offerings. Our expert usability analyses provide documented evidence on the safety and efficacy of your product, while our quality system management and data security practices support compliance with your design history file needs.
Technical / Regulatory Services
Known Use Problems
Functional / Task Analysis
URRA: Use Related Risk Assessment
User Specification Development
Summary of Usability
Human Factors / Usability Research
Identify use-related risks, refine design, and enhance usability through iterative formative testing in preparation for your HF validation study. Ensure your product’s user interface meet the needs of your users, confirm design inputs, and evaluate the effectiveness of risk control methods prior to validating the clinical or commercial design.
HF/Usability Research Services
Simulated and/or Actual Use
Patient Therapeutic Assessment
- Device/Combination Product Prototype Design
- Training Material and/or Training Program
- IFU Comprehension
- Packaging & Labeling
- User Needs Comparative Devices
Validation Testing
Human Factors Support Service Offerings
Promote safety, compliance, and success at every stage through our comprehensive HF support services. We offer a variety of services to help support HF program and/or HF study needs.
HF Support Services
Material Development
- IFU: Instructions for Use
- Research Materials
- Training Program/Materials
Research Documentation Support
- Document Development
- Risk Assessment Development/Review
HF Consulting
- Clinical Study/HF SME
- HF Documentation Support
- User Material Development
- Clinical Study Staff Training
Research Study Ancillary Services
- Transcriptions
- Video/Storyboard Clips
- Video Streaming
- GCP aligned documentation
- Translation services