Clinical Outcome Assessment Consulting

PAREXEL® provides expert scientific and operational services to optimize the design and implementation of studies that include the collection of COA data. These services include the selection of the most relevant instrument(s) for studies, their refinement and application in a new setting if required, as well as new instrument development. Study implementation planning expertise is then available to optimise data quality and operational expertise is applied to data collection, analysis, interpretation and reporting of studies.  Our project management and procurement expertise also enables us to effectively manage the contribution of niche services and technology providers as required. Our expert capabilities include:

Development, modification and validation of instruments
PAREXEL’s core questionnaire development activities are patient diaries and surveys to capture patient reported data in late phase studies. PAREXEL has successfully designed and implemented hundreds of questionnaires in many different languages.  PAREXEL can also create, modify and perform validation of instruments to meet stringent regulatory requirements including cognitive debriefing, user acceptance testing as well as equivalence testing or full psychometric validation.

PAREXEL can perform clinical studies to pilot newly created or modified instruments in a target population, facilitated by access to investigators in most major markets, who assist by providing country and culture-specific guidance, as well as in-country data collection.

Conducting qualitative and quantitative research  
PAREXEL offers high-level market research expertise and implementation capabilities. We are able to identify specific patient populations and conduct interviews in the local language as well as convening and facilitating patient focus groups. Individuals are identified using a number of different access routes including via treating physicians. Our approach combines a commitment to understanding context, using effective research methods, and providing insightful results. In addition, PAREXEL can quantitatively advise on the relative financial impact of selecting specific instruments and advising on those with the greatest likelihood of achieving a positive financial outcome.

Translation and linguistic validation
PAREXEL works with a small number of established and highly respected industry leaders who can provide global specialist PRO translation and validation services. These specialist providers are integrated and managed as part of the PAREXEL study project team.