Patient-Centered Endpoints (PaCE)
Scientific and strategic solutions for measuring what is important to patients
Benefit from our scientific and strategic expertise in clinical outcome assessments (COAs) to support regulatory approval and payer interactions. Our Patient-Centered Endpoints (PaCE) team collaborates to seamlessly support your clinical development program. We have expertise in:
- COA strategy aligned with Patient Focused Drug Development (PFDD) guidance
- Identifying, developing and validating clinical outcomes assessments (COAs)
- Study design and modes of data collection for Patient Reported Outcomes (PRO) and other COAs
- Generation of fit-for-purpose validity evidence to achieve regulatory and reimbursement agency acceptance
Strategic partner for your program
Design your endpoint measurement strategy for your asset around patients to support regulatory approval and differentiate your asset for reimbursement authorities.
Pragmatic solutions tailored to your program
Our team generates patient experience and COA validity evidence data tailored to your program to meet regulatory guidance and maximizing the return on investment.
Scientific and operational excellence
Dedicated team of PhD-level COA scientists with over 100 years of combined experience developing and executing patient centered research balancing site and patient burden
Tailored patient-centered endpoint strategy for your product
Whether you are in early or late phase development, you will benefit from our pragmatic approach to the generation of patient experience data to support the development and validation of different types of COAs to measure clinical trial endpoints. Our experts have extensive experience in all aspects of patient centered research from developing endpoint measurement strategies, to pragmatic generation of COA validity evidence through communicating with regulatory and reimbursement authorities regarding the interpretation and value of data collected using COAs.
Access a suite of complementary solutions
Enhance your strategy with our comprehensive solutions:
- COA endpoint strategies
- COA instrument selection and development
- Qualitative and mixed-methods research studies
- Clinical trial embedded interviews
- Oversight of COA administration in clinical trials
- Quantitative psychometric and meaningful change analyses
- COA validity evidence generation and communication
