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Measurement Strategy & Analyses

An optimized approach to PRO and other
outcome measurement.

Our research consultants are available to guide your selection, use, development, and testing of patient-reported outcome (PRO) assessments and other clinical outcome assessments (COAs), such as observer-reported outcomes (ObsROs), caregiver-reported instruments, clinician-reported outcomes (ClinROs), and other types of measures. Leveraging our regulatory and sector expertise, we develop recommendations and strategies for modifying existing PROs, developing new PROs and obtaining the evidence to support their validation.

 

Our goal is to help you incorporate the COA tools best suited to your research goals, an ideal assessment schedule for gathering patient data, and analytical approaches that lead to valid, critical evidence.

Clinical Endpoint Selection

Identifying additional endpoints of value to patients relevant to their overall functioning and well-being.

Landscape Analysis

Delivering insights on the clinical and commercial landscape for your disease area, revealing new areas of opportunity.

Regulatory Support

Guide COA measurement strategies in accordance with standards of regulatory agencies worldwide, including the FDA and EMA.

Generate actionable insights from PRO data

We help you draw analytical conclusions that give new focus and clarity to your clinical research, project or program.

Supporting your ability to capture and interpret the patient’s perception of:

Treatment Efficacy

Evaluate treatment approaches and effectiveness, including ongoing changes in symptoms, side effects, patient adherence to regimens and overall impact on daily activities.

Health Status

Evaluate a patient’s general condition and current disease symptoms. Learn how a disease affects certain activities over time, irrespective of treatment, as well as which affected activities the patient values most.

Optimizing global clinical development programs

We help optimize your development strategies by injecting vital patient insights into your product lifecycle. With the patient’s input, you can concentrate your investments on the most promising compounds for enhancing treatment benefits. Our approach is designed to strengthen submissions of benefit evidence for approval.