Instrument Development

If no instrument exists that targets your concepts/endpoints, can you confidently develop a new instrument and demonstrate its development history and performance to regulators?

Our Instrument Development Services create instruments to assess key concepts in a target population that meet international regulatory expectations.

 

Service Service Description
Item Generation Our scientists will create items (questions that patients are asked) that will be used to develop a preliminary PRO instrument
Cognitive Interviewing & Debriefing Our scientists will test the items that have been created in order to determine if patients can appropriately understand, interpret and utilize the questionnaire
V1 Instrument Finalization We will integrate patient feedback regarding the items to allow for the development of a finalized instrument (ready for validation testing)