Refining Patient Reported Outcomes
News & Events
- WEBINAR: Patient Non-Compliance with Diaries - Paper vs. Electronic Diary Methods
- invivodata and PRO Consulting Open Registration for PROficiency™ 2012 Conference on Patient Perspective in Clinical Research
- PROficiency 2012 - PROs and Beyond, invivodata and PRO Consulting's Annual Conference
- WEBINAR: Using PROs to Assess Comparative Safety and Tolerability - Methodological and Regulatory Considerations (DIA hosted)
Patient Reported Outcomes Experts
PRO Consulting®, a division of invivodata®, inc., provides consulting services to help clinical research teams effectively develop, execute, and document patient reported outcome (PRO) strategies to support their clinical research objectives. The PRO Consulting team has more than 265 years of cumulative experience in psychometrics, patient reported outcomes study design, and migrating and validating electronic solutions to collect PRO data, and has extensive experience working with the FDA and other regulatory bodies.
PRO Consulting offers a variety of services to help clinical research teams, including:
- Concept Evaluation
- Conceptual Model Development
- Instrument Evaluation
- Instrument Selection
- Instrument Modification
- Instrument Development
- PRO Statistical Services
- Regulatory Meeting Support
- Translation & Linguistic Validation
- Paper to Electronic Migration
- Scientific Communication Services
Uncertain about the regulatory implications of your PRO instrument? Register for a FREE PRO Gap Analysis which will help identify the steps you can take to reduce risks and ensure the success of your PRO-based clinical development program.
Be alerted to what's new in the world of patient reported outcomes
Clinical Outcomes Assessments (COAs) Webinar & Brief
On October 19, 2011 the FDA conducted a public workshop to discuss measurement principles for Clinical Outcome Assessments (COAs) used in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. The workshop outlined FDA’s expectations for the development and qualification to establish that COAs are fit for purpose and appropriate for their context of use. invivodata and our PRO Consulting division will host a webinar on Monday, November 14 at 11:00 AM Eastern reviewing the highlights of the workshop. Register for the webinar now!
In addition to the webinar, you can DOWNLOAD A MEETING BRIEF on the FDA workshop.