PRO Consulting Services
PRO Consulting provides expertise to biopharmaceutical developers when making decisions about the strategies, concepts, and instruments for capturing Patient Reported Outcomes data in clinical programs. Our focus is on the PRO strategy and instruments used to assess treatment benefits. These are typically the primary or key secondary endpoints in trials and form the basis of labeling claims. Further, we have extensive experience supporting these strategies and instruments for clients as they work with the FDA, EMA, and other regulatory bodies.
We have developed our portfolio of consulting services to meet the needs of our clients – international biopharmaceutical and medical device product developers using PRO in their clinical development. We also routinely customize and develop new services to help our clients identify their PRO-related needs and meet their program objectives.
Not sure if PRO Consulting is right for you? Our variety of services will help you answer these important questions:
Concept Evaluation
Do you know what symptoms are the most important and relevant to your target patient population?
Conceptual Model Development
Can you defend to regulatory bodies how your targeted concepts (i.e., subjects’ “pain points”) are linked to your desired label claims?
PRO Instrument Evaluation
Do you need to find the PRO instruments that already exist so that you can determine their feasibility for your program, and defensible to regulators?
PRO Instrument Selection
If instruments already exist, do you know how to confidently select and use the one that best meets your needs?
PRO Instrument Modification
If an instrument exists, do you know how to confidently modify it to ensure it measures your targeted concepts and desired endpoints?
PRO 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?
PRO Statistical Services
Do you need assurance that your selected instrument is statistically performing in the way you thought, or in ways consistent with scientific and regulatory expectations?
Regulatory Meeting Support
Are you confident that your interactions with regulatory bodies on PRO strategy will be successful?
Translation & Linguistic Validation
If your study is global, are you confident that your measure says and asks what you think it does in different languages and locations?
Paper to Electronic Migration (PRO to ePRO)
Are you migrating an instrument from paper format to an electronic modality? Are you confident that migration didn’t change any of the instruments’ properties and will comply with regulatory guidelines?
Scientific Communication Services
Do you need assistance in communicating your PRO results to the scientific community?
