PRO development tailored to your needs

Our research team is highly experienced in developing, modifying, and validating patient-reported outcome (PRO) measures for diverse healthcare and life science market needs, ensuring we meet each client’s specific purpose.

Qualitative Research

Our qualitative research team is highly skilled in conducting concept elicitation interviews with patients, key opinion leaders, and clinical experts to identify and develop key concepts best suited for measuring your patients’ disease, treatment experience and quality of life.

In addition, the team has expertise in conducting cognitive debriefing interviews to ensure that the items, instructions, response choices, and other aspects of newly developed instruments or modifications to items of existing instruments are well understood by patients and other key stakeholders, such as caregivers. Leveraging decades of regulatory insight, our qualitative approach to instrument development is aligned with specific regulatory guidelines and industry best practices.

Quantitative Research

Our quantitative research team has decades of experience in the application of both classical test theory and modern psychometric methods in the development and evaluation of new or existing PRO instruments.

We can apply these same best practices for instruments being developed for clinical use or other applications that do not require meeting regulatory guidelines.

Service Benefits

• Develop study protocols for collecting PRO data
• Write statistical analysis plans aimed at assessing the psychometric properties of newly developed or existing PRO instruments
• Conduct psychometric analyses to provide necessary evidence of reliability, validity, and responsiveness that meet regulatory guidelines
• Deliver comprehensive technical reports and/or PRO dossiers for regulatory submission